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IECEE
OD-2044 Ed. 2.2
OPERATIONAL & RULING DOCUMENTS
Evaluation of Risk Management in
medical electrical equipment according
to the IEC 60601-1 & IEC/ISO 80601-1
Series of Standards
Except for IECEE members and mandated persons, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher
IECEE Secretariat, 3, rue de Varembé, Geneva, Switzerland, e-mail : [email protected]
OD-2044 Ed. 2.2
2013-11-20
© IEC – IECEE 2013
Contents
Contents .............................................................................................................................................2
1
Scope ..........................................................................................................................................4
2
Reference documents ..................................................................................................................4
3
Terms and definitions ...................................................................................................................4
4
Application of Risk Management Principle for IEC 60601 series CB Scheme investigations ........5
4.1
5
6
General .................................................................................................................................5
Assessment of Risk Management principles in the IEC 60601 series CB Scheme investigations 5
5.1
General principles .................................................................................................................5
5.2
Implementation of ISO 14971 into the IEC 60601 series .......................................................6
5.3
ISO 14971:2000 (1st edition) and ISO 14971:2007 (2nd edition) .............................................6
5.4
Description of ISO 14971 clauses application in regards to IEC 60601-1 standard ...............7
5.5
Evaluating RISK - HAZARDS identified in the IEC 60601-series .........................................12
5.6
Evaluating RISK - HAZARDS not identified in the IEC 60601-series ...................................13
5.7
Risk Management Flowchart (Reference to the ISO 14971:2007, 2nd edition – Figure B.1) .14
5.8
IEC 60601-1 Test Report Form (TRF) .................................................................................15
5.9
Workflow .............................................................................................................................17
5.10
Application of Risk Management to the General and Collateral Standards ..........................17
Clause mapping guide IEC 60601 / ISO 14971 ..........................................................................18
6.1
Application of ISO 14971:2000 in IEC 60601-1:2005 product evaluation.............................18
Clause 4 – General requirements...............................................................................................18
Clause 5 – General requirements for testing MEE .....................................................................20
Clause 7- MEE Identification, markings and documents.............................................................20
Clause 8 - Protection against electrical hazards from MEE ........................................................22
Clause 9 - Protection against mechanical hazards of MEE and MES .........................................24
Clause 10 - Protection against unwanted and excessive radiation hazards................................26
Clause 11 - Protection against excessive temperatures and other hazards................................27
Clause 12 - Accuracy of controls & instruments; protection against hazardous outputs .............29
Clause 13 - Hazardous situations and fault conditions ...............................................................30
Clause 14 - Programmable Electrical Medical Systems (PEMS) ................................................30
Clause 15 - Construction of MEE ...............................................................................................31
Clause 16 – ME Systems ...........................................................................................................33
Clause 17 – Electromagnetic compatibility of MEE and MES .....................................................34
6.2
Application of ISO 14971:2007 in IEC 60601-1:2005 + A1:2012 product evaluation ...........35
Clause 4 – General requirements...............................................................................................35
6.3
IEC 60601-1-3:2008 / ISO 14971:2000 ...............................................................................36
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6.4
IEC 60601-1-6:2010 / ISO 14971:2007 / IEC 62366:2007...................................................39
6.5
IEC 60601-1-8:2006 / ISO 14971:2000 ...............................................................................43
6.6
IEC 60601-1-10:2007 / ISO 14971:2000 .............................................................................45
6.7
IEC 60601-1-11:2010 / ISO 14971:2000 .............................................................................47
6.8
IEC 62304:2006…………………………………………………………………………………….47
Annex 1
ISO 14971:2000 Checklist (Informative) ..........................................................................50
Annex 2
ISO 14971:2007 Checklist (Informative) ..........................................................................50
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1 Scope
The scope of this procedure is to provide a uniform approach to the CBTL and Manufacturer on how to
assess and document compliance with the relevant clauses of IEC 60601 standard series related to the
standard ISO 14971.
2 Reference documents
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
IEC 60601-1:2005 Incl. Am 1:2012 Medical equipment – Part 1: General requirements for basic safety and
essential performance (Also known as IEC 60601-1:2005 + A1:2012)
IEC 60601-1-2:2007 Medical electrical equipment - Collateral standard: Electromagnetic compatibility Requirements and tests
Note: The RM requirements are addressed through the IEC 60601-1:2005
IEC 60601-1-3:2008 Medical electrical equipment - Collateral Standard: Radiation protection in diagnostic Xray equipment
IEC 60601-1-6:2010 Medical electrical equipment - Collateral Standard: Usability
IEC 60601-1-8:2006 Medical electrical equipment - Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-10:2007 Medical electrical equipment - Collateral Standard: Requirements for the development
of physiologic closed-loop controllers
IEC 60601-1-11:2010 Medical electrical equipment - Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
IEC 62366:2007 Medical devices – Application of usability engineering to medical devices
IEC 62304:2006 Medical device software – Software life cycle processes
ISO 14971:2000 Medical devices – Application of risk management to medical devices
ISO 14971:2007 Medical devices – Application of risk management to medical devices
IEC60601_1G – IECEE Test Report Form - IEC 60601-1: 2005 + CORR. 1(2006) + CORR 2 (2007)
IEC60601_1H – IECEE Test Report form - IEC 60601-1: 2005 + AM1 (2012)
3 Terms and definitions
For the purposes of this Operational Document, the terms and definitions of ISO 14971 standard and IEC
60601 standard series apply.
For the purpose of this document, the Risk Management Process is a management system intended to
address all activities related to ISO 14971.
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For the purpose of this document, unless otherwise specified, the following conventions are used:
· IEC 60601-1:2005 or IEC 60601-1:2005 + A1:2012 designates "the general standard" alone;
· IEC 60601-1 designates reference to IEC 60601-1:2005 and IEC 60601-1:2005 + A1:2012
· IEC 60601-1-nn designates a specific collateral standard (this applies for all the collateral standards
stated in this document where “nn” is the number of the collateral)
· IEC 60601 series designates the combination of the general standard IEC 60601-1:2005/IEC 606011:2005 + A1:2012 and the collateral standards IEC 60601-1-nn.
· ISO 14971 designates references to ISO 14971:2000 and ISO 14971:2007
4 Application of Risk Management Principle for IEC 60601 series CB Scheme
investigations
4.1 General
The third edition of IEC 60601-1:2005 is the primary standard in a series of standards that covers safety and
essential performance of medical electrical equipment. It is the first IEC standard in the scope of the CB
Scheme that incorporates risk management principles according to ISO 14971:2000. The introduction of Risk
Management is the reason for this Operational Document.
The existence of a CB Test Certificate does not solely establish legal market entry. However, it could be used
to help substantiate a request for legal market access.
This Operational Document is related solely to the IECEE CB Scheme and is intended for use by those
individuals with a working knowledge of risk management for medical electrical equipment and the provisions
of the IEC 60601 series.
NOTE: IEC 60601-1:2005 + A1:2012 incorporates risk management principles according to ISO 14971:2007.
5 Assessment of Risk Management principles in the IEC 60601 series CB
Scheme investigations
5.1 General principles
There is a general requirement to perform the risk management process as specified in ISO 14971:2000 (IEC
60601-1:2005, Clause 4.2.) or ISO 14971:2007 (IEC 60601-1:2005 + A1:2012, Clause 4.2.2).
The registration to ISO 13485 is not sufficient to demonstrate that a risk management process compliant with
ISO 14971 requirements is performed. There can be no investigation to IEC 60601 series without the
manufacturer’s Risk Management File being available, unless specifically permitted by the rules of the CB
Scheme.
The CB Test Report and Certificate confirms that there is a Risk Management Process performed which
complies with the risk management requirements of IEC 60601 series and the applicable requirements of ISO
14971. This does not mean that a complete Risk Management System in compliance with ISO 14971 is in
place. The CB Test Report is only a snapshot in time and does not necessarily assess all top management
responsibilities.
Several clauses of ISO 14971 define the requirements for the application of the Risk Management Process to
“the particular medical device being considered”. When those clauses of ISO 14971 are used to address Risk
Management requirements in IEC 60601-1, the verification shall confirm whether the Risk Management
Process is correctly applied to the particular Device Under Evaluation/Test.
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A separate certification of registration to ISO 14971 indicates that a risk management system conforming to
ISO 14971 is in place, but does not necessarily provide the risk management device specific documentation
to meet the requirements of IEC 60601 series. IEC 60601 series requires specific Risk Management activities
to be done and the CB Test Report requires objective evidence that these activities have been performed for
the Device Under Test.
A CB Scheme Test Certificate does not imply that an audit of the manufacturer’s Risk Management System
was conducted.
In view of the above and similar to the second edition, the CB Test Report according to IEC 60601- 1 is not
necessarily a guarantee of certification by an accepting NCB.
A certificate of registration may be requested for local or regional certification to IEC 60601 series as it relates
to follow-up services. There may be differences in requirements that are the subject of local legal market entry
requirements.
5.2 Implementation of ISO 14971 into the IEC 60601 series
In the clauses of IEC 60601-1 series there are three types of references to ISO 14971 Risk Management
requirements:
a)
Direct reference to Risk Management Process as specified by ISO 14971 (for example clause 4.2 or
4.2.2).
b)
Test related references to give appropriate alternative to the application of laboratory testing with
specific pass/fail criteria or to select appropriate tests to be performed on the specific product (for
example clause 5.7).
c)
Indirect reference to offer additional elements to be considered in the implementation of the Risk
Management Process specified by ISO 14971 for the specific product. (for example clause 14.1)
The manufacturer can also identify alternative means to provide an equivalent safety level to IEC 60601
series. The manufacturer may implement new and original approaches to developing effective means of
protection against unacceptable risks. The manufacturer must verify that the residual risks that result from
applying the alternative means are equal to or less than the residual risks that result from applying the
requirements of IEC 60601 series. All these activities must be performed in accordance with the requirements
of ISO 14971.
Clause 4.2 of IEC 60601-1:2005 and Clause 4.2.2 of IEC 60601-1:2005 + A1:2012 do not require post market
monitoring (e.g. clause 9 of ISO 14971) of the effectiveness of the risk control measures
Tables appended in Clause 6 of this Operational Document provide mapping with all the clauses of IEC
60601-1 and the IEC collaterals standards which require risk management, and the applicable clauses in ISO
14971. These tables provide guidance and considerations for application and assessment of RM criteria.
5.3 ISO 14971:2000 (1st edition) and ISO 14971:2007 (2nd edition)
The process of standards development progresses over a significant length of time. The IEC 60601 series of
standards to which this Operational Document refers were published between 2005 and 2010. When IEC
60601-1:2005 was published and consequentially its collateral standards published, the risk management
standard used as reference was the ISO 14971:2000.
This situation is not valid when referring to IEC 60601-1-6:2010 which includes a direct link to IEC
62366:2007. The IEC 62366:2007 also refers directly to ISO 14971:2007. This situation is also not valid when
referring to IEC 60601-1:2005 + A1:2012 which also makes a direct reference to ISO 14971:2007.
For this reason, in the tables appended that provide mapping with all the clauses of IEC 60601 series, the
following references have been made:
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·
·
·
ISO 14971:2000 clauses are used to address the risk management process required by IEC 60601-1
series aligned with IEC 60601-1:2005;
ISO 14971:2007 clauses used to address the risk management process required by IEC 60601-1
series aligned with IEC 60601-1:2005 + A1:2012;
ISO 14971:2007 clauses are used to address the risk management process required by IEC
62366:2007 (IEC 60601-1-6:2010).
5.4 Description of ISO 14971 clauses application in regards to IEC 60601-1 standard
The following Table is a guidance document. Refer to standard ISO 14971 for more detailed requirements
and supporting rationales. This table explains what action or evidence is required for each clause of ISO
14971.
IEC 60601-1 TRF – RM RESULTS TABLE 4.2 – Risk Management Process
4.2
RM RESULTS TABLE: Risk Management Process for ME Equipment or
ME Systems
Clause of
ISO 14971
Document Ref. in RMF
(Document No. and
paragraph)
– Main topic of clause
Result – Remarks
- What type of objective evidence would be
required in the Document Ref.
3.3a
(2000) or
3.2 (2007)
Management
responsibilities
Requires that the manufacturer define and document the
policy for determining criteria for risk acceptability; this
policy ensures that criteria are based upon applicable
national or regional regulations and relevant International
Standards, and takes into account available information
such as the generally accepted state of the art and known
stakeholder concerns. The CBTL must review the
manufacturer’s policy and verify that it meets these
requirements. This review is done once, as is
recommended to be completed early in the risk
management review process.
ISO 14971:2007, additionally requires an assessment
to ensure the manufacturer will allocate sufficient
resources and assign trained personnel to the risk
management process
P
3.3 (2007
only)
Qualification of
personnel
Requires the personnel performing risk management tasks
to have the appropriate knowledge and experience for the
tasks assigned to them. This includes knowledge and
experience related to the medical device(s), their use,
technologies involved and risk management techniques.
The manufacturer is required to maintain qualification
records
P
3.5e
(2000) or
3.4 (2007)
Risk management plan
The criteria for risk acceptability are based on the
manufacturer’s policy for determining acceptable risk,
including criteria for accepting risks when the probability of
occurrence of harm cannot be estimated. The
manufacturer’s risk management process must include the
risk acceptability criteria. The CBTL must review the
manufacturer’s risk acceptability criteria and verify that it
meets established requirements. This review is done once,
as is recommended to be completed early in the risk
management review process
P
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Verdict
© IEC – IECEE 2013
Verdict
Clause of
ISO 14971
Document Ref. in RMF
(Document No. and
paragraph)
– Main topic of clause
Result – Remarks
- What type of objective evidence would be
required in the Document Ref.
3.5 (2007
only)
Risk management file
Requires the manufacturer to estabilish and maintain a file
containing the results of the risk management activities
including all documentation requirements specified in ISO
14971 and traceability for each identified hazard to: the risk
analysis, the risk evaluation, risk control measures and
acceptance of residual risks
P
4.1
Risk analysis process
Risk analysis shall be performed for the particular medical
device as described in 4.2 to 4.4. The implementation of
the planned risk analysis activities and the results of the
risk analysis shall be recorded in the risk management file.
P
In addition to the records required in 4.2 to 4.4, the
documentation of the conduct and results of the risk
analysis shall include at least the following:
a) a description and identification of the medical device that
was analyzed;
b) identification of the person(s) and organization who
carried out the risk analysis;
c) scope and date of the risk analysis
4.2
Intended use and
identification of
characteristics related to
the safety of the medical
device
For the particular medical device being considered, the
manufacturer documents the intended use and reasonably
foreseeable misuse. The manufacturer identifies and
documents those qualitative and quantitative
characteristics that could affect the safety of the medical
device and, where appropriate, their defined limits. This
documentation shall be maintained in the risk management
file. The CBTL must review the risk management file and
verify that based on the device, the manufacturer has
complied with these requirements. Note that the
identification of characteristics that could affect safety,
needs to include those hazard based requirements from
the IEC 60601 series of standards where clause 4.2 of ISO
14971 is a required element. This review repeats for each
IEC 60601 series hazard based risk management
requirement.
P
4.3
Identification of hazards
The manufacturer compiles documentation on known and
foreseeable hazards associated with the medical device in
both normal and fault conditions. The manufacturer
processes identified risks through hazard
identification→event(s) or circumstance(s) leading to a
hazardous situation→hazardous situation→event(s) or
circumstance(s) leading to harm→harm→who or what is
harmed. For those hazard based requirements that are
applicable to the medical device, the CBTL uses this
information for completing clause 4.3 and 4.4 of the IECEE
Risk Management Results Tables. The CBTL reviews and
verifies compliance for all of the applicable hazard based
risk management requirements.
P
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Verdict
Clause of
ISO 14971
Document Ref. in RMF
(Document No. and
paragraph)
– Main topic of clause
Result – Remarks
- What type of objective evidence would be
required in the Document Ref.
4.4
Estimation of the risk(s)
for each hazardous
situation
The manufacturer determines and documents rreasonably
foreseeable sequences or combinations of events that can
result in a hazardous situation and records the resulting
hazardous situation(s).
P
For each identified hazardous situation, the manufacturer
estimates the associated risk(s) using available information
or data. For hazardous situations for which the probability
of the occurrence of harm cannot be estimated, the
possible consequences shall be listed for use in risk
evaluation and risk control. The results of these activities
shall be recorded in the risk management file.
Any system used for qualitative or quantitative
categorization of probability of occurrence of harm or
severity of harm shall be recorded in the risk management
file.
The CBTL reviews the risk analysis and risk estimation and
enters verification of each of the hazards based risk
management analysis and risk estimation in the test results
table.
5
Risk evaluation
For each identified hazardous situation, the manufacturer
shall decide, using the criteria defined in the risk
management plan, if risk reduction is required. If risk
reduction is not required, the requirements given in 6.2 to
6.6 do not apply for this hazardous situation. The results of
this risk evaluation shall be recorded in the risk
management file.
P
The CBTL reviews the manufacturer’s risk evaluation for
each hazard based risk required by the IEC 60601 series
of standards and enters a verdict in the Risk Management
Results Table. The CBTL uses this information for test
plans and conducting tests.(e.g. unacceptable performance
becomes essential performance).
6.1
Risk reduction
When risk reduction is required, risk control activities, as
described in 6.2 to 6.7, shall be performed.
P
6.2
Risk control option
analysis
The manufacturer identifies risk control measure(s) that are
appropriate for reducing the risk(s) to an acceptable level.
The manufacturer uses one or more of the following risk
control options in the priority order listed:
a) inherent safety by design;
b) protective measures in the medical device itself or in the
manufacturing process;
c) information for safety
P
The manufacturer records the risk control measure(s) in
the risk management file.
If, during risk control option analysis, the manufacturer
determines that required risk reduction is not practicable,
the manufacturer shall conduct a risk/benefit analysis of the
residual risk (proceed to 6.5).
The CBTL reviews the manufacturer’s chosen risk control
measure(s) for each hazard based requirement from IEC
60601 series of standards and documents their findings in
the Risk Management Results Tables in the TRF.
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Verdict
Clause of
ISO 14971
Document Ref. in RMF
(Document No. and
paragraph)
– Main topic of clause
Result – Remarks
- What type of objective evidence would be
required in the Document Ref.
6.3
Implementation of risk
control measure(s)
The manufacturer implements the identified risk control
measure(s). The manufacturer verifies the implementation
of each hazard based risk control measure. The
effectiveness of the risk control measure(s) shall be verified
and the results shall be recorded in the risk management
file.
P
The CBTL reviews manufacturer’s implementation,
verification and effectiveness of risk control measure(s) for
each hazard based requirement from IEC 60601 series of
standards and documents their findings in the Risk
Management Results Tables in the TRF.
6.4
Residual risk evaluation
After the risk control measures are applied, the
manufacturer evaluates any residual risk using the criteria
defined in the risk management plan. The results of this
evaluation are recorded in the risk management file.
P
If the residual risk is not judged acceptable using these
criteria, then the manufacturer applies further risk control
measures.
For residual risks that are judged acceptable, the
manufacturer decides which residual risks to disclose and
what information is necessary to include in the
accompanying documents in order to disclose those
residual risks.
The CBTL reviews the manufacturer’s residual risk
analysis, risk control looping where necessary, and their
determination of information to be included in the
accompanying documents. The CBTL verifies compliance
with these requirements and records their findings in the
Risk Management Results Tables of the TRF for each
hazard based risk management from the IEC 60601 series
of standards.
6.5
Risk/benefit analysis
If the residual risk is not judged acceptable using the
criteria established in the risk management plan and further
risk control is not practicable, the manufacturer may gather
and review data and literature to determine if the medical
benefits of the intended use outweigh the residual risk. If
this evidence does not support the conclusion that the
medical benefits outweigh the residual risk, then the risk
remains unacceptable. If the medical benefits outweigh the
residual risk, then proceed to 6.6.
P
For risks that are demonstrated to be outweighed by the
benefits, the manufacturer shall decide which information
for safety is necessary to disclose the residual risk.
The CBTL is responsible for carefully reviewing the
manufacturers’ risk management file and entering their
findings in the Risk Management Results table.
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Verdict
Clause of
ISO 14971
Document Ref. in RMF
(Document No. and
paragraph)
– Main topic of clause
Result – Remarks
- What type of objective evidence would be
required in the Document Ref.
6.6
Risks arising from risk
control measures
The manufacturer reviews the effects of the risk control
measures with regard to:
a) the introduction of new hazards or hazardous situations;
b) whether the estimated risks for previously identified
hazardous situations are affected by the introduction of the
risk control measures.
P
The manufacturer processes newly identified hazards or
hazardous situations through their risk management
process and reprocesses risks that are affected by the
introduction of risk control measures through initial risk
estimation, risk evaluation and if necessary, risk control.
The CBTL reviews the manufacturers’ risk management file
and records their findings in the TRF Risk Management
Results Table.
6.7
Completeness of risk
control
The manufacturer ensures that the risk(s) from all identified
hazardous situations have been considered. The results of
this activity are recorded in the risk management file.
P
The CBTL reviews the manufacturers’ risk management file
and records their findings in the Risk Management Results
Table
7
Evaluation of overall
residual risk
acceptability
After all risk control measures have been implemented and
verified, the manufacturer decides if the overall residual
risk posed by the medical device is acceptable using the
criteria defined in the risk management plan.
P
If the overall residual risk is not judged acceptable using
the criteria established in the risk management plan, the
manufacturer may gather and review data and literature to
determine if the medical benefits of the intended use
outweigh the overall residual risk. If this evidence supports
the conclusion that the medical benefits outweigh the
overall residual risk, then the overall residual risk can be
judged acceptable. Otherwise, the overall residual risk
remains unacceptable.
For an overall residual risk that is judged acceptable, the
manufacturer shall decide which information is necessary
to include in the accompanying documents in order to
disclose the overall residual risk.
The CBTL reviews the manufacturers’ risk management file
regarding their overall residual risk and records a verdict in
the TRF Risk Management Results Table.
8
(2007
only)
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Risk management report
Requires the manufacturer to prepare a report prior to
commercial release documenting a review of the risk
management process (specific to activities on specific
devices). The report is intended to ensure that the risk
management plan was properly implemented, the overall
residual risk is acceptable and there are appropriate
methods in place to collect and analyze production and
post-production information.
The portion of the requirement related to production and
post-production information is outside the scope of
assessment under the IECEE CB Scheme
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5.5 Evaluating RISK - HAZARDS identified in the IEC 60601-series
The requirements of this standard shall be applied in the following way when evaluating RISK:
a) Where this standard or its collateral or particular standards specify requirements addressing particular
HAZARDS, together with specific acceptance criteria, compliance with these requirements is presumed to
establish that the RESIDUAL RISKS have been reduced to acceptable levels unless there is OBJECTIVE
EVIDENCE to the contrary.
EXAMPLE 1: Sub-clause 8.5.1.2, MEANS OF PATIENT PROTECTION (MOPP)
EXAMPLE 2: Sub-clause 9.4.2.1, Instability in transport position
Compliance is checked by satisfying the relevant requirements of this standard and its collateral and particular
standards.
b) Where this standard or its collateral or particular standards specify requirements addressing particular
HAZARDS but do not provide specific acceptance criteria, the MANUFACTURER shall provide the
acceptance criteria for which the RESIDUAL RISK shall be acceptable according to the criteria for RISK
acceptability recorded in the RISK MANAGEMENT plan.
EXAMPLE 3: Sub-clause 9.8.3.3, Dynamic forces due to loading from persons (Note: IEC 60601-1:2005 +
A1:2012 removes reference to unacceptable RISK and replaces the text with reference to maintaining BASIC
SAFETY and ESSENTIAL PERFORMANCE)
EXAMPLE 4: Sub-clause 11.6.3, Spillage on ME EQUIPMENT and ME SYSTEM
Compliance is checked by confirming that the documentation in the RISK MANAGEMENT FILE demonstrates
that after applying the specific requirements of this standard and the acceptance criteria determined by the
manufacturer the RESIDUAL RISK is acceptable using the criteria for RISK acceptability recorded in the RISK
MANAGEMENT plan, i.e. no unacceptable RISK remains. Only the relevant parts of the RISK
MANAGEMENT FILE need to be reviewed, e.g. MANUFACTURER'S calculations or test results, or the
determination of RISK
c) Where this standard or its collateral or particular standards identify particular HAZARDS that have to be
investigated without providing specific technical requirements:
– The MANUFACTURER shall determine whether such HAZARDS exist for the particular ME EQUIPMENT or
ME SYSTEM, and
– where such HAZARDS exist for the particular ME EQUIPMENT or ME SYSTEM, the MANUFACTURER
shall evaluate and (if necessary) control these RISKS following the RISK MANAGEMENT PROCESS
specified in 4.2/4.2.2.
EXAMPLE 5: Sub-clause 10.2, Alpha, beta, gamma, neutron and other particle radiation Compliance is
checked by confirming that the documentation in the RISK MANAGEMENT FILE demonstrates that the
RESIDUAL RISK is acceptable using the criteria for RISK acceptability recorded in the RISK MANAGEMENT
plan, i.e. no unacceptable RISK remains.
Only the relevant parts of the RISK MANAGEMENT FILE need to be reviewed, e.g. MANUFACTURER'S
calculations or test results, or the determination of RISK acceptability.
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NOTE: When ME EQUIPMENT or an ME SYSTEM has been designed in such way that for a certain type of
HAZARD no HAZARDOUS SITUATION exists, no further RISK ASSESSMENT for that HAZARD is
necessary. This can be verified by tests or inspections.
5.6 Evaluating RISK - HAZARDS not identified in the IEC 60601-series
For HAZARDS that are identified for the particular ME EQUIPMENT or ME SYSTEM but are not specifically
addressed in the Standard IEC 60601-1 or its collateral or particular standards, the MANUFACTURER shall
address those HAZARDS in the RISK MANAGEMENT PROCESS as specified in 4.2.2.
EXAMPLE 6: ME EQUIPMENT or an ME SYSTEM for which there are particular RISKS but no particular
standard
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
Clause 4.2 of ISO 14971 has caused confusion when used with the IEC 60601 series of standards. The
manufacturers Intended Use statement is information that the CBTL can use to understand the intended
purpose of the product. The manufacturer must identify and document a list of qualitative and quantitative
characteristics that could affect safety. Where clause 4.2 of ISO 14971 is called out in the hazard based
clauses of IEC 60601 series, the CBTL must use the manufacturers’ list of qualitative and quantitative
characteristics that could affect safety. For example, high humidity for extended period of time, the
manufacturer should have identified and documented the intended use environment.
One of the IEC 60601-1:2005 risk management requirements is process based and not hazard based. This
requirement will not be found in the manufactures hazard identification. The process based clause is 4.2 and
it is expected that the manufacturer will have implemented appropriate system procedures to address this
clause.
Four of the elements (requirements) of ISO 14971 only require single use/review including 3.3 a), 3.5 e), 6.7
and 7 since they are process requirements rather than hazard based requirements. Note that not all of the
elements (requirements) of ISO 14971 are required by the IEC 60601 series of standards.
The manufacturer addresses the hazard based clauses of the IEC 60601 series of standards according to the
ME Equipment. The Risk Management Results Tables in the TRFs are based on the requirements of the IEC
60601 series of standards. For a specific hazard, a manufacturers’ risk management file may go beyond the
specific Risk Management Results Table, or the manufacturers’ risk management file may use only a portion
of the risk management elements and, therefore, it is acceptable to enter NA into some of the identified ISO
14971 Risk Management Results Table clauses based on the specific risk for the ME Equipment.
For hazard based risk management requirements, the flow diagram below shows the steps that the
manufacturer must consider. For example, if they complete risk evaluation with an acceptable level of risk,
they may not proceed to risk control.
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5.7 Risk Management Flowchart (Reference to the ISO 14971:2007, 2nd edition – Figure B.1)
The following flowchart is used to process each identified hazard
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5.8 IEC 60601-1 Test Report Form (TRF)
To assess the requirements for Risk Management process required by IEC 60601 series, the CB Scheme
utilizes Risk Management Results tables within the IEC 60601 series TRF in conjunction with the test data
tables, containing reference to the manufacturer's documents intended to support objective evidence of
compliance.
For a clause from IEC 60601-1 which makes reference to the RM file refer to TABLE 1 - IEC 60601- 1 / ISO
14971 CLAUSE MAPPING GUIDE to identify which clauses from ISO 14971 need to be documented.
For example, IEC 60601-1:2005 Clause 9.2.4 which requires reference to the RM file; Table 1 of this OD 2044
specifies that documents demonstrating compliance with clauses 4.2 to 6.6 of ISO 14971:2000 shall be
provided for evaluation.
9.2.4
Emergency stopping devices
- Does the MEE use emergency stopping devices?
- Are risks caused by mechanical hazards which are reduced
by the use of the emergency stopping devices reduced to an
acceptable level?
4.2 to
6.6
The actual clauses that are to be used to provide evidence are referenced in the Risk Management Results
Tables of the TRF; the ISO 14971 range of clauses in table 1 is given for reference only.
After evaluation, the 9.2.4 Risk Management Results Table shall be filled in appropriately.
9.2.4
Risk Management Results Table: Emergency stopping devices
Pass
Clause
ISO 14971
Document Ref. in RMF
(Document No. & paragraph)
Result- Remark
Verdict
4.2
See document 453627 rev 1
Product Specifications
The Treadmill is intended to make a patient walk on a
moving belt.
Pass
4.3
See document 1234567 rev 1
clause 13.1a
The possible hazard of the patient tripping has been
identified.
Pass
4.4
Document 7654321 – rev 2
Refer to clause 13.1a
The probability of occurrence of the harm has been
estimated in “ProbRange C”.
The severity of the harm has been estimated as
“SevRange B”
Pass
5
Document 7654321 – rev 2
Refer to clause 13.1a
The risk has been evaluated as “TBR = To Be
Reduced”
Pass
6.2
Document 7654321 – rev 2
Refer to clause 13.1a
The measure that has been identified to control the
risk is the use of an emergency stopping device.
Pass
6.3
Document 1726354 – rev 3
Design Verification
The Treadmill is provided with an emergency
stopping device.
Pass
6.4
Document 1726354 – rev 3
Design Verification
The emergency stopping device works as intended.
The probability of occurrence of the harm has been
reduced to “ProbRange A”.
The residual risk has been evaluated as “acceptable”.
Pass
6.5
Not deemed necessary
N/A
6.6
No other hazards generated
Pass
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IEC 60601-1:2005 Clause 11.6.3 which requires reference to the RM file; Table 1 of this OD 2044 specifies
that documents demonstrating compliance with clauses 4.2 to 6.5 of ISO 14971:2000 shall be provided for
evaluation.
11.6.3
RM RESULTS TABLE: Spillage on ME equipment and ME system
Pass
Clause of
ISO 14971
Document Ref. in RMF
(Document No. & paragraph)
Result - Remarks
Verdict
4.2
See document 453627 rev 1
Product Specifications
See document 1234567 rev 1
clause 7.1
The Treadmill is provided with a cup holder.
Spillage of liquids may occur.
Pass
The possible hazard of electric shock to the
patient caused by the insulation breakdown
has been identified.
For the purpose of the test, the following test
conditions have been identified:
Type of liquid: mineral water
Volume: 1 liter
Duration of spill: 15 s
Point of contact: on the end of the belt above
the drum motor from a height not exceeding 5
cm
Pass
4.4
Document 7654321 – rev 2
Refer to clause 7.1
The probability of occurrence of the harm has
been estimated in “ProbRange C”.
The severity of the harm has been estimated
as “SevRange A”
Pass
5
Document 7654321 – rev 2
Refer to clause 7.1
Document 7654321 – rev 2
Refer to clause 7.1
Document 1726354 – rev 3
Design Verification
The risk has been evaluated as “TBR = To Be
Reduced”
Pass
The measure that has been identified to control
the risk is a protective cover to the motor.
Pass
The Treadmill is provided with a protective
cover
Pass
No wetting of uninsulated electrical parts or
electrical insulation of parts could result in a
Hazardous Situation.
The probability of occurrence of the harm has
been reduced to “ProbRange A”.
The residual risk has been evaluated as
“acceptable”.
Pass
Not deemed necessary
N/A
4.3
6.2
6.3
6.4
Document 1726354 – rev 3
Design Verification
6.5
Compliance with those sub-clauses in IEC 60601-1 that refer to "minimizing risk" are deemed satisfied if the
manufacturer can show that the particular condition or event does not result in an unacceptable risk.
Compliance with those sub-clauses in IEC 60601-1 that require protection against a particular condition or
event that "could result in a hazardous situation" are deemed to be satisfied if the manufacturer can show that
the particular condition or event does not result in an unacceptable risk.
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5.9 Workflow
1.
Based on the latest TRF version, establish the relevant clauses of IEC 60601 series that have to be
supported by RM documentation.
2.
Verify the required documentation and identify the relevant reference points to be listed in the TRF. To
initiate the assessment process of a manufacturer, the CBTL may use attachment 1, from this
Procedure (ISO 14971:2000 Checklist), attachment 2 from this Procedure (ISO 14971:2007 Checklist)
or equivalent. The form is intended to facilitate an understanding of the manufacturer’s risk management
procedures. The completion of this form documents the assessment of the manufacturer’s risk
management process. (Note: It is not necessary to maintain a copy of the risk management file).
3.
In case the use of RM influences the tests (see clause 5.2)
4.
3.1
Identify the test to be conducted
3.2
Identify the test parameters and conditions to be used performing the tests
3.3
Identify the RM Pass/Fail criteria. The Pass/Fail criteria and the rationale for
acceptance shall be reported in the TRF.
Perform verification and report the results in the TRF tables.
5.10 Application of Risk Management to the General and Collateral Standards
The evaluation of clauses and sub-clauses of IEC 60601-1 containing risk management requirements are
provided in Table 1 of this document, Clause Mapping Guide.
The evaluation of clauses and sub-clauses in IEC 60601-1-nn, Collateral standards containing risk
management requirements are provided in Tables 1-3 through 1-11 of this document.
Note: Guidance has not yet been developed by the task force for IEC 60601 3rd edition particular standards IEC 606012-nn. The collateral standard IEC 60601-1-2:2007 does not contain any risk management requirements, the RM
requirements are addressed through the IEC 60601-1 (Clause 17).
There is no planned guidance for IEC 60601-1-9:2007.
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6 Clause mapping guide IEC 60601 / ISO 14971
6.1 Application of ISO 14971:2000 in IEC 60601-1:2005 product evaluation
IEC 60601-1:2005 (Ed.3) Medical electrical equipment, Part 1: General requirements for basic safety
& essential performance - Guidance for the application of ISO 14971:2000 (Ed.1)
Clause 4 – General requirements
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
4.2
Risk
Management
Process for ME
Equipment or
ME Systems
Compliance is checked by inspection of the risk management
file. The requirements of this clause and all requirements of this
standard referring to inspection of the risk management file are
considered to be satisfied if the manufacturer has:
- established a risk management process; and
- established acceptable levels of risks; and
- demonstrated that the residual risk is acceptable
Does the manufacturer have a risk management process
according to ISO14971:2000 in place?
Was this process used for the device being considered?
If so, a limited number of more detailed questions can be
addressed at this point:
· Are all risk management procedures (that meet the
requirements of ISO14971:2000, including acceptability
criteria) developed and applied for the device considered
(clauses 3.3 a), 3.5 e), 4 to 7 of ISO14971:2000)?
· Is there a risk management plan (including resources and
commitment) for the device considered (clause 3.3 a), 3.5 e)
of ISO14971:2000)?
· Is the overall residual risk for the device considered
acceptable (clause 7 of ISO 14971:2000)?
3.3 a),
3.5 e),
4 to 7
4.3
Essential
performance
Compliance is checked by inspection of the risk management
file.
Have, apart from the essential performance identified in the
particular standards, hazardous situations been identified
whereby the residual risk is unacceptable due to the absence of
performance of the device?
If so, has this performance been identified as essential
performance for the device during the risk assessment process?
If so, have risk control measures or particular tests been
identified to check whether this performance is maintained?
If so, has this been checked by inspection or by functional test?
4.2 to 5
4.5
Equivalent safety
for ME
Equipment of ME
System
Compliance is checked by inspection of the risk management
file.
Are there particular risks for which alternative means of
controlling these risks are applied such that the resulting risk
level is acceptable for these risks?
If so, have these risks been identified as such during the risk
assessment process?
If so, is the resulting risk level equal or less than the residual risk
that results from applying the requirements of this standard?
4.2 to 5,
6.2 to 6.5
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IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
4.6
ME equipment or
ME system parts
that contact the
patient
Compliance is checked by inspection of the risk management
file. Have parts been identified during the risk management
process which can come into contact with the patient but fall
outside the definition of applied parts?
If so, are all the relevant requirements and tests of this standard
applied?
If so, are there residual risks which are not acceptable?
If so, are risk controls measures implemented that make the
residual risk acceptable?
4.2 to 6.5
4.7
Single Fault
Condition for ME
Equipment
Compliance is determined by applying the specific requirements
and tests associated with the single fault conditions identified in
13.2, and tests for the failures identified from evaluation of the
results of the risk analysis. Compliance is determined if the
introduction of any of the single fault conditions described in
13.2, one at the time, does not lead directly to the hazardous
situations described in 13.1, or any other outcome that results in
an unacceptable risk.
Are there single fault conditions which lead directly to hazardous
situations described in 13.1 or to risks that are unacceptable?
4.2 to 4.4
4.8
Components of
ME Equipment
Compliance is checked by inspection and, where necessary, by
test. The tests of this standard for motors (see 13.2.8 and
13.2.13.3) and transformers (see 15.5.3) are considered to be
comprehensive and together with the evaluation of the motor or
transformer insulation system according to Table 22 represent
all testing required by this standard. ME system components
that provide isolation from non-ME equipment are evaluated to
clause 16.
Are specific exceptions made for any component of the device
under investigation to allow it to be used not in accordance with
its specified rating?
If so, are these exceptions formulated as the result of the risk
management process?
If so, have inspection or test requirements been formulated to
make the hazardous situations acceptable?
4.2 to 6.5
4.9
Use of
components with
high-integrity
characteristics in
ME
Compliance is checked by inspection of the risk management
file and the selection criteria for the components with highintegrity characteristics.
Are components with high-integrity characteristics applied?
If so, have the risks associated with its use been identified as
such during the risk assessment process, or in other words are
they selected and evaluated consistent with their conditions of
use and reasonably foreseeable misuse during the expected
service life of the ME equipment?
4.2 to 6.5
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Clause 5 – General requirements for testing MEE
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
5.1
Type Tests
The tests to be performed are determined taking into
consideration the requirements of clause 4, in particular 4.2.
For the selection of the tests to be performed, is a risk
management process according to ISO14971:2000 applied?
If so, this requirement is fulfilled.
The results of the risk analysis are used to determine which
combination(s) of simultaneous faults are to be tested.
For the determination of which combination(s) of simultaneous
faults have to be tested, is a risk assessment applied?
4.2 to 4.4
5.4 a)
Other conditions
Unless otherwise specified in this standard, ME equipment is to
be tested under the least favourable working conditions as
specified in the Instructions for Use that are identified during the
risk analysis.
For testing of the ME equipment, have the least favourable
working conditions been identified via the risk analysis?
4.2 to 4.4
5.7
Humidity
preconditioning
treatment
Where the risk management process suggests that the ME
equipment can be exposed to high humidity for extended
periods, the period is extended appropriately.
Has it been determined via the application of the risk
management process whether the ME equipment can be
exposed to high humidity for extended periods?
If so, is the period for testing been extended appropriately
following the conclusions of the risk management process?
4.2 to 6.5
5.9.2.3
Actuating
mechanisms
Inspection of the risk management file demonstrates that the
relevant part is unlikely to become detached unintentionally
during the expected service life of the ME equipment.
Has the result of the risk analysis demonstrated that the relevant
part is unlikely to become detached unintentionally during the
expected service life time of the ME equipment and that an
acceptable residual risk results?
4.2 to 6.5
Clause 7- MEE Identification, markings and documents
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
7.2.2
Identification
ME Equipment and its detachable parts not marked with the
name or trademark of the manufacturer and with a Model or
Type reference does not present an unacceptable risk?
4.2 to 5,
6.4
7.2.5
ME Equipment
intended to
receive power
from other
equipment
Are the model or Type reference of the specified other
equipment marked if this could result in an unacceptable risk?
4.2 to 5,
6.4
7.2.13
Physiological
effects (safety
signs and
warning
statements)
Do the instructions for use describe the nature of the HAZARD
and the precautions for avoiding it or minimizing the associated
RISK?
4.2 to 5,
6.3
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IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
7.2.17
Protective
packaging
Can premature unpacking of ME Equipment or its parts result in
an unacceptable RISK?
Is the packaging marked with a suitable safety sign?
4.2 to 5,
6.3, 6.4
7.3.3
Batteries
Are there lithium batteries or fuel cells which are incorporated
where incorrect replacement could result in an unacceptable
RISK? If so, is there a warning indicating that replacement by
inadequately trained personnel could result in a HAZARD?
4.2 to 5,
6.3
7.3.7
Supply terminals
Are Terminals for supply conductors marked adjacent to the
terminals? If not, does the identification of known or foreseeable
hazards (risk management file) demonstrate that no
HAZARDOUS SITUATION can result if connections are
interchanged?
4.3
7.4.2
Control devices
In normal use, can the change of the setting of a control result in
an unacceptable RISK to the patient? If so, review the
manufacturers risk management file for risk analysis, risk
evaluation and where necessary implementation of risk control.
4.2 to 5,
6.2, 6.3
7.5
Safety signs
Is marking used to convey a warning, prohibition or mandatory
action that mitigates a RISK that is not obvious to the operator?
If so, review the manufacturers risk management file for risk
analysis, risk evaluation and where necessary implementation of
risk control.
4.3 to 5,
6.3
7.9.1
General
accompanying
documents
format. (see also
Table C.4)
Compliance is checked by inspection of the risk management
file.
Has the manufacturer applied the risk management process to
determine which information also needs to be provided as hard
copy or as marking on the ME equipment?
4.2 to 5,
6.2, 6.3
7.9.2.4
Electrical power
source
If leakage from a battery would result in an unacceptable RISK,
do the instructions for use include a warning to remove the
battery if the ME Equipment is not likely to be used for some
time? If so, review the manufacturers risk management file for
risk analysis, risk evaluation and where necessary
implementation of risk control.
If loss of power would result in an unacceptable risk, do the
instructions for use include a Warning that the ME Equipment
must be connected to an appropriate power source? If so,
review the manufacturers risk management file for risk analysis,
risk evaluation and where necessary implementation of risk
control.
4.2 to 5,
6.3
7.9.3.2
Replacement of
fuses, power
supply cords and
other parts
Where replacement of a component could result in an
unacceptable RISK, is there appropriate warnings to identify the
nature of the HAZARD and, if the Manufacturer specifies the
component as replaceable by service personnel, is all
information necessary to safely replace the component? Review
the manufacturers risk management file for risk analysis, risk
evaluation and where necessary risk control measures.
4.2 to 6.5
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Clause 8 - Protection against electrical hazards from MEE
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
8.1 b
Fundamental
rule of protection
against electric
shock
1. Has the manufacturer identified in their risk analysis if the
interruption of any one power carrying conductor between MEE
parts in separate enclosures might cause permitted limits
(voltage, current, energy) to be exceeded?
If so, then during product safety verification, this must be one of
the SFC’s tested.
2. Has the manufacturer identified in their risk management
process that a component’s movement must be considered as a
SFC because its lack of securement (8.10.1) over the expected
service life of the MEE may cause permitted limits (voltage,
current, energy) to be exceeded?
If so, then during product safety verification, this must be one of
the SFC’s tested.
3. Has the manufacturer identified in their risk management
process accidental detachment of conductors and connectors?
If so, then during product safety verification, this must be one of
the SFC’s tested
b(1) 4.3 &
4.4
b(2) 4.2 to
6.5
b(3) 4.3
8.2.2
Connection to an
external d.c.
power source
Does ME Equipment specified for power supplied from an
external d.c. power source, have no HAZARDOUS SITUATION,
other than absence of essential performance, develop when a
connection with the wrong polarity is made? Review the
manufacturers risk management file for risk analysis and risk
evaluation.
4.2 to 5
Does the ME Equipment, when connection is subsequently
made with the correct polarity, provide freedom from
unacceptable RISK? Review the manufacturers risk
management file for risk analysis and risk evaluation.
8.3 d
Classification of
applied parts
Has the manufacturer identified in their risk management
process the need for parts (not being applied parts) to be
subject to the requirements for an applied part of Type BF or
Type CF?
If so, then during product safety verification, these parts are to
be tested accordingly.
6.2
8.4.2 c
Accessible parts
including applied
parts
Has the manufacturer identified parts (not being applied parts)
where a current exceeding the allowable touch current could
flow, either directly or through the body of an operator, however,
the risk analysis determined that the probability in normal use is
negligible?
If so, then during product safety verification, these identified
parts do not require touch current testing. Inspect the
instructions for use includes instructions for the operator not to
touch the relevant part and the patient simultaneously.
4.2-4.4
8.5.2.2
Type B applied
parts
Has the manufacturer identified in their risk management file,
unearthed Type B applied parts that are not separated from
unearthed conductive accessible parts, however, determined
that the level of risk that the unearthed accessible part will make
contact with a source of voltage or leakage current above
permitted limits is acceptably low?
If so, accepted.
If not, then one means of protection is required.
4.2 to 5
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IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
8.5.2.3
Patient Leads
Has the manufacturer identified in their risk management
process connectors for electrical connections on a patient lead
at the end of the lead remote from the patient and that contains
a conductive part that is not separated from all patient
connections by one MOPP for a working voltage equal to the
maximum mains voltage, that will not present an unacceptable
risk from contact with objects other than a mains socket or a flat
surface (e.g. corners or edges)?
If so, during product safety verification, the test using a straight,
rigid test finger with a force of 10 N is not required, however, the
remaining inspections of this clause are required.
4.2 to 5
8.6.3
Protective
earthing of
moving parts
Does the manufacturer’s risk management file indicate the need
to bond moving parts to the protective earth connection?
If so, has the manufacturer demonstrated the reliability of the
connection during the expected service life?
4.2 to 6.5
8.8.4.1
Mechanical
strength and
resistance to
heat
Has the manufacturer identified in the risk management file the
need for insulations of all types, considering its resistance to
heat in the application and the expected service life?
Has the manufacturer identified any specific test protocols that
must be performed during product safety verification?
If so, conduct the tests required in this clause and any additional
tests or inspections identified in the risk management file.
4.2 to 6.5
8.10.1
Fixing of
components
Has the manufacturer identified components the movement of
which could result in an unacceptable risk in their risk
management file?
If so, verify that such identified components are securely
mounted and will remain so for the expected service life.
4.2 to 6.5
8.10.2
Fixing of wiring
Has the manufacturer identified in their risk management file the
need to restrain by double securement any conductors and
connectors where if they were to break free and touch circuit
points this could result in a hazardous situation?
If so, inspect the construction and restraint of these conductors
and connectors to ensure that they are held in place by use of
double securement.
4.3 to 6.5
8.10.5
Mechanical
protection of
wiring
Has the manufacturer identified in the risk management file the
need to protect against contact with moving parts, friction at
sharp corners and edges or damage during assembly or the
opening or closing of access covers of internal cables, wiring,
cord forms or components, where the damage or insulation
damage could result in a hazardous situation?
If so, inspect these parts carefully considering their location and
potential damage during assembly, disassembly, contact with
moving parts and friction at sharp corners and edges.
4.3 to 6.5
8.11.5
Mains fuses and
over-current
releases
Has the manufacturer provided justification for omission of fuses
or over-current releases in the risk management file?
If so, inspect the circuit according to the requirements of this
clause ensuring double insulation and acceptable fault condition
tests results.
4.3 to 6.5
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Clause 9 - Protection against mechanical hazards of MEE and MES
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
9.2.1
Hazards
associated with
moving parts General
Are protective measures used to reduce the risk from contact
with moving parts?
Considering use as indicated in the Accompanying Documents
or reasonably foreseeable misuse and bearing in mind the ease
of access, the ME Equipment function, the shape of the parts,
the energy and speed of the motion and the benefits to the
patient, is this risk reduced to an acceptable level?
Is exposure to moving parts needed for MEE to perform its
intended function?
Have all reasonable protective measures including warning
markings on the MEE where the hazards persist been
implemented?
4.2 to 6.5
9.2.2.4.3
Movable guards
Are the risks caused by mechanical hazards associated with
moving parts and reduced by use of the movable guards
addressed?
4.2 to 6.5
9.2.2.4.4
Protective
measures
Are the risks caused by mechanical hazards associated with
moving parts and reduced by the use of protective measures
incorporated in the control system addressed?
4.2 to 6.5
9.2.2.5 c
Continuous
activation
Are the risks caused by mechanical hazards associated with
accessibility to a trapping zone and reduced by use of the
continuous activation of the movement control addressed?
4.2 to 6.5
9.2.2.6
Speed of
movement(s)
Are the risks caused by mechanical hazards associated with the
speed of movement addressed?
4.2 to 6.5
9.2.3.2
Over travel
Are the risks caused by mechanical hazards associated with the
over travel addressed?
4.2 to 6.5
9.2.4
Emergency
stopping devices
Does the MEE use emergency stopping devices?
Are risks caused by mechanical hazards which are reduced by
the use of the emergency stopping devices reduced to an
acceptable level?
4.2 to 6.6
9.2.5
Release of
patient
Are the risks caused by mechanical hazards associated with
release of patient addressed?
4.2 to 6.5
9.3
Hazards
associated with
surfaces,
corners and
edges
Are the risks caused by mechanical hazards associated with
surfaces, corners and edges addressed?
4.3 to 6.5
9.4.2.4.3
Movement over
a threshold
Are the risks caused by mechanical hazards associated with
movement over a threshold addressed?
4.2 to 6.5
9.5.1
Protective
means
Have the risks caused by mechanical hazards associated with
expelled parts been addressed?
4.3 to 6.5
9.6.1
Acoustic energy
- General
Have the risks caused by mechanical hazards associated with
acoustic energy and vibration been addressed?
4.2 to 6.5
9.6.2.2
Infrasound and
ultrasound
energy
Have the risks caused by mechanical hazards associated with
infrasound and ultrasound energy been addressed?
4.2 to 6.5
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Subject
Considerations for application of RM criteria
ISO 14971
Clauses
9.7.2
Pneumatic and
hydraulic parts
Have the risks caused by mechanical hazards associated with
pneumatic and hydraulic parts been addressed?
4.3 to 6.5
9.7.4
Pressure rating
of ME equipment
parts
Have the risks caused by mechanical hazards associated with
pressure rating of MEE parts been addressed?
4.3 to 6.5
9.7.6
Pressure-control
device
Have the risks caused by mechanical hazards associated with
pressure – control device been addressed?
4.3 to 6.5
9.7.7
Pressure-relief
device
Have the risks caused by mechanical hazards associated with a
pressure-relief device been addressed?
4.3 to 6.5
9.8.1
Hazards
associated with
support systems
- General
Have the risks caused by hazards arising from static, dynamic,
vibration, impact and pressure loading, foundation and other
movements, temperature, environmental, manufacture and
service conditions been addressed?
Were all of the following failures considered: excessive
deflection, plastic deformation, ductile or brittle fracture, fatigue
fracture, instability (buckling), stress-assisted corrosion cracking,
wear, material creep, and material deterioration?
Were the following residual stresses resulting from the
manufacturing process, e.g. machining, assembling, welding,
heat treatment or surface coating considered?
4.2 to 6.5
9.8.2
Tensile safety
factor
When not according to Table 21, what alternative method was
used to determine the tensile safety factor?
Have the risks related to the value of the tensile factor been
addressed?
4.3 to 6.5
9.8.3.1
Strength of
patient or
operator support
or suspension
systems General
Have the risks caused by mechanical hazards associated with
support or suspensions of the patient (including particular
applications) been addressed?
4.2 to 6.5
9.8.3.2 a, b
Static forces due
to loading from
persons
Have the risks caused by mechanical hazards associated with
static forces due to loading from persons been addressed?
4.3 to 6.5
9.8.4.1
Systems with
mechanical
protective
devices- General
Does the MEE use mechanical protective devices?
Does the mechanical protective device activate before travel
(movement) produces an unacceptable risk?
4.3 to 6.5
9.8.4.3
Mechanical
protective device
intended for
single activation
Does the MEE use mechanical protective devices intended for
single activation?
Where risks caused by mechanical hazards which have been
reduced by the use of mechanical protective devices intended
for single activation:
4.3 to 6.5
9.8.5
Systems without
mechanical
protective
devices
Has the manufacturer determined that the use of mechanical
protective devices in the MEE is not required?
Has the manufacturer justified the reasons not to use
mechanical protective devices?
4.3 to 6.5
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Clause 10 - Protection against unwanted and excessive radiation hazards
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
10.1.2
ME equipment
intended to
produce
diagnostic or
therapeutic Xradiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of X-radiation in
the risk management file?
4.2 to 6.5
10.2
Alpha, beta,
gamma, neutron
and other
particle radiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of alpha, beta,
gamma, neutron or other particle radiation in the risk
management file?
4.2 to 6.5
10.3
Microwave
radiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of microwave
radiation in the risk management file?
4.2 to 6.5
10.5
Other visible
electromagnetic
radiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of visible
electromagnetic radiation in the risk management file?
4.2 to 6.5
10.6
Infrared radiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of infrared
radiation in the risk management file?
4.2 to 6.5
10.7
Ultraviolet
radiation
When applicable, has the manufacturer identified hazards and
hazardous situations associated with production of ultraviolet
radiation in the risk management file?
4.2 to 6.5
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Clause 11 - Protection against excessive temperatures and other hazards
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
11.1.1
Maximum temperature during normal use
ISO 14971
Clauses
Table 23
Has the manufacturer identified parts of the ME Equipment that
are likely to be touched in normal or foreseeable misuse that
can contact more than 10% of the surface area operator or
patient’s body or 10% of the surface area of the patient’s or
operator’s head?
Has the manufacturer identified the duration of continuous or
aggregate contact?
Has the manufacturer identified and addressed such risks?
Has the RM process determined suitable limits for temperature
based on the risk acceptability criteria and risk benefit analysis
in association with patient state of health and whether adult,
pediatric or neonate?
4.2 to 6.5
Table 24
Has the manufacturer identified applied parts of the ME
Equipment that can contact more than 10% of the surface area
operator or patient’s body or 10% of the surface area of the
patient’s or operator’s head during normal or foreseeable
misuse?
Has the manufacturer identified the duration of continuous or
aggregate contact of these applied parts?
Has the manufacturer identified and addressed such risks?
Has the RM process determined suitable limits for temperature
based on the risk acceptability criteria?
If the temperature limits exceed the values in table 24 has a
favorable risk benefit analysis in association with patient state of
health and whether adult, pediatric or neonate been
documented?
4.2 to 6.5
11.1.2.1
Applied parts
intended to
supply heat to a
patient
Is any part of the ME Equipment intended to supply heat or
otherwise intended to cool a patient?
Has the manufacturer identified and addressed the clinical risks
associated with hazards?
Has the manufacturer disclosed such risks?
4.2 to 6.5
11.1.2.2
Applied parts not
intended to
supply heat to a
patient
Does the ME equipment have any applied parts that are not
intended to heat or cool the patient that could in normal or
foreseeable misuse exceed 41 °C or cool below ambient
temperature?
4.2 to 6.5
11.1.3 e
Measurements
Has the manufacturer identified hazardous situations that relate
to maximum heating effect of nearby surfaces?
If no hazardous situations are apparent has the manufacturer
made appropriate declarations in the RMF?
Has the manufacturer identified all conditions of intended use
and foreseeable misuse to determine occurrence and duration
of contact with parts and applied parts that could be touched?
4.2 to 6.5
11.2.2.1
Risk of fire in an
oxygen rich
environment
Has the manufacturer identified that there is a risk of fire from an
oxygen rich environment?
Where scenario number 3 is applicable, has the manufacturer
conducted a risk assessment to determine hazards associated
with leaks or component failures causing a source of ignition
been conducted?
4.2 to 6.5
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IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
11.3
Constructional
requirements for
fire enclosures of
ME equipment
Have the specific requirements of this clause been employed to
comply with cl 13.1.2?
Has the manufacturer analyzed and addressed risks of not
complying with the constructional requirements and showed
than an equivalent level of risk / benefit has been provided?
4.2 to 6.5
11.5
ME equipment
and ME systems
intended for use
in conjunction
with flammable
agents
Is the ME Equipment intended to (or can it through foreseeable
misuse) come into contact with flammable agents?
4.2 to 6.5
11.6.2
Overflow in ME
Equipment
Does a HAZARDOUS SITUATION or unacceptable risk due to
overflow develop if transportable ME Equipment is tilted through
an angle of 15°? Review the manufacturers risk management
file for risk analysis and risk evaluation.
Does wetting of uninsulated electrical parts or electrical
insulation of parts that could result in a HAZARDOUS
SITUATION occur? Review the manufacturers risk management
file for risk analysis and risk evaluation.
4.2 to 5
11.6.3
Spillage on ME
equipment and
ME system
Does the ME Equipment require the handling of liquids in normal
or foreseeable misuse?
Could the wetting of the ME equipment result in a hazardous
situation?
Has the manufacturer identified hazardous situations relating to
the worst case volume and type of liquid?
Has the manufacturer identified hazardous situations relating to
the worst location for the equipment to spill?
4.2 to 6.5
11.6.5
Ingress of water
or particulate
matter into ME
Equipment and
ME Systems
Does the ME Equipment show no signs of bridging of insulation
(or electrical components) that could result in a HAZARDOUS
SITUATION in normal condition or in combination with a single
fault condition? Review the manufacturers risk management file
for risk analysis and risk evaluation.
4.2 to 5
11.6.6
Cleaning and
disinfection of
ME equipment
and ME systems
Has the manufacturer identified the parts of the ME equipment
which may be subject to cleaning or disinfection in normal or
foreseeable misuse and the type of cleaning or disinfection?
Based on the ESL of the ME equipment has the manufacturer
extrapolated the number of cleaning processes to which the
equipment will be subjected?
Has the manufacturer identified all related hazards and
addressed such risks in the RMF?
4.2 to 6.5
11.6.7
Sterilization of
ME equipment
and ME systems
Has the manufacturer identified the parts of the ME equipment
which may be subject to sterilization in normal or foreseeable
misuse and the type of sterilization?
4.2 to 6.5
11.6.8
Compatibility
with substances
used with the
ME equipment
Has the manufacturer identified all substances to which the ME
Equipment may come into contact with in normal or foreseeable
misuse?
4.2 to 6.5
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Clause 12 - Accuracy of controls & instruments; protection against hazardous outputs
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
12.1
Accuracy of
controls and
instruments
Has the manufacturer identified all controls and instruments
contained on the ME Equipment?
Has the manufacturer conducted a hazard analysis to identify
the risks associated with the accuracy of the above identified
controls and instruments?
4.2 to 6.5
12.3
Alarm systems
Has the manufacturer considered in their option analysis the
inclusion of alarms as a means to mitigate the risk of accuracy
of controls and instruments for controlling hazards against
hazardous outputs?
If yes, has the use of alarms been implemented as a means of
mitigating the risk of accuracy of controls and instruments for
controlling hazards against hazardous outputs?
If yes, has the manufacturer in their risk analysis explored and
addressed the hazards of operation or failure of the alarm
systems?
Does the residual risk of such hazards meet IEC 60601-1-8?
4.2 to 6.5
12.4.1
Intentional
exceeding of
safety limits
Has the manufacturer identified risks associated with the
intentional exceeding of safety limits?
Has the manufacturer addressed such risks to comply with the
manufacturer’s risk acceptability criteria?
4.2 to 6.5
12.4.2
Indication of
parameters
relevant to safety
Has the manufacturer identified all functions related to the
delivery of energy or substances to the patient?
Has the manufacturer explored such functions for hazardous
situations in which these functions can produce an output to the
patient?
4.2 to 6.5
12.4.3
Accidental
selection of
excessive output
values
Has the manufacturer identified all features of the ME
Equipment that provide an output to the patient for therapeutic
purposes?
Has the manufacturer identified which of these features have
multiple purposes that require different intensities for different
treatments?
Has the manufacturer identified hazards associated with
accidental selection of excessive output values?
4.2 to 6.5
12.4.4
Incorrect output
Has the manufacturer identified all features of the ME
Equipment that provide an output?
Has the manufacturer identified hazards associated with
incorrect output?
4.2 to 6.5
12.4.5.2
Diagnostic X-ray
equipment
Has the manufacturer identified if the product emits intentional
X-ray radiation for diagnostic purposes?
Has the manufacturer identified and explored risks associated
with emission of X-Ray radiation for diagnostic purposes?
4.2 to 6.5
12.4.5.3
Radiotherapy
equipment
Has the manufacturer identified if the product is intended for
radiotherapy purposes?
Has the manufacturer identified and explored risks associated
with emission radiation for therapeutic purposes?
4.2 to 6.5
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Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
12.4.5.4
Other ME
equipment
producing
diagnostic or
therapeutic
radiation
Has the manufacturer identified if the product is intended for
radiotherapy purposes?
Has the manufacturer identified and explored risks associated
with emission radiation for therapeutic purposes?
4.2 to 6.5
12.4.6
Diagnostic or
therapeutic
acoustic
pressure
Has the manufacturer identified if the equipment emits an
acoustic pressure output?
Has the manufacturer identified and explored risks associated
with emission of such acoustic pressure?
4.2 to 6.5
Clause 13 - Hazardous situations and fault conditions
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
13.2.6
Leakage of liquid
Has the manufacturer determined the appropriate test conditions
for the evaluation of liquid leakage?
4.2 to 6.5
Clause 14 - Programmable Electrical Medical Systems (PEMS)
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
14.1
Programmable
electrical medical
systems - General
Does the application of ISO 14971 demonstrate that the failure
of the PEMS does not lead to an unacceptable risk?
4.2 to 5
14.6.1
Identification of
known and
foreseeable
hazards
Has the manufacturer considered those hazards associated
with the software and hardware aspects of the PEMS including
those associated with Network/Data coupling and legacy
subsystems?
4.3
14.6.2
Risk control
Has the manufacturer identified suitable tools and procedures
to implement risk control measures?
Are these tools and procedures appropriate to ensure that
each risk control measure effectively reduces the identified
risks?
6.1
14.7
Requirement
specification
Does the requirement specification include and distinguish any
risk control measures?
6.3
14.8
Architecture
Does the architecture specification reduce the risk to an
acceptable level, where appropriate, using levels a) – f)?
Does the architecture specification take into consideration
allocation of risk control measures?
6.3
14.9
Design and
Implementation
Is descriptive data regarding the design environment included
in the risk management file?
6.2, 6.3
14.10
Verification
Is the result of the verification activity documented?
Have all functions that implement risk control measures been
verified?
6.3
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Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
14.11
Programmable
electrical medical
systems - PEMS
validation
Has the manufacturer documented the professional
relationships of the members of the PEMS Validation team
with members of the design team?
Is a reference to the methods and results of the PEMS
Validation included in the risk management file?
6.3
14.13
Connection of
PEMS by
network/data
coupling to other
equipment
Is there a list of the HAZARDOUS SITUATIONS resulting from
a failure of the network/data coupling provided with the
specified characteristics? Review the manufacturers risk
management file for any risk analysis, risk evaluation and any
necessary risk control measures.
Does a connection of the PEMS to a network/data coupling
that includes other equipment result in previously unidentified
RISKS to patients, operators or third parties? Review the
manufacturers risk management file for any risk analysis, risk
evaluation and any necessary risk control measures.
4.2 to 5,
6.2, 6.3
Clause 15 - Construction of MEE
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
15.1
Construction of
ME equipment Arrangements of
controls and
indicators of ME
equipment
Has the manufacturer identified in the risk management
process the risks associated with the arrangement of controls
and indicators?
If so, inspect for the arrangement of controls and indicators.
4.2 to 6.5
15.3.2
Push test
After the push test, were damages sustained that result in an
unacceptable risk identified?
4.2 to 5
15.3.3
Impact test
After the impact test, were damages sustained that resulted in
an unacceptable risk identified?
4.2 to 5
15.3.4.2
Portable ME
equipment
After the drop test, were damages sustained that resulted in an
unacceptable risk identified?
4.2 to 5
15.3.5
Rough handling
test
After the rough handling test, were damages sustained that
resulted in an unacceptable risk identified?
4.2 to 5
15.4.1
Construction of
connectors
Has the manufacturer identified electrical, hydraulic, and
pneumatic or gas connection terminals and connectors
removable without the use of a tool where incorrect connection
to other outlets intended for other functions would not result in
unacceptable risks?
If so, ensure that incorrect connection does not result in an
unacceptable risk. (Gas connectors must comply with item b) of
this clause).
4.2 to 6.5
15.4.2.1 a
Temperature and
overload control
devices
- Application
Has the manufacturer identified in the risk management file,
any automatic resetting thermal cut-outs or over-current
releases where their use would not result in an unacceptable
risk?
If so, ensure that the resetting of these devices does not result
in unacceptable risks.
4.2 to 5
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IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
15.4.2.1 b
Application
Has the manufacturer identified in the risk management file the
use of thermal cut-outs with a safety function?
If so, ensure that such components are not of the types that
have to be reset by a soldering operation that can affect the
operating value.
4.2 to 4.4
15.4.2.1 c
Application
Has the manufacturer identified the use of a thermostat in the
MEE in the risk management file?
If so, inspect for an independent non-self-resetting thermal cutout with a setting outside the maximum range of the thermostat
but within the safe temperature limit for its intended function.
4.2 to 4.4
15.4.2.1 d
Application
Has the manufacturer identified that loss of function of the MEE
could result in a hazardous situation?
If so, ensure that the operation of a thermal cut-out or overcurrent release does not result in an unacceptable risk.
4.2 to 4.4
15.4.2.1 h
Application
Has the manufacturer identified the need for fusing each lead
for the use of tubular heating elements in the risk management
file?
If so, inspect for fuses in both leads and fault either lead to
ground and ensure over-heating does not occur.
4.2 to 4.4
15.4.3.1
Housing
Has the manufacturer identified the need for ventilated battery
housings where gases that could result in a hazard can escape
during charging or discharging?
If so, inspect the battery housings for proper ventilation.
Has the manufacturer identified the need for battery polarity
connection construction such that short-circuiting is not
possible?
If so, inspect the battery connection and ensure that incorrect
connection is not possible.
4.2 to 4.4
15.4.3.2
Connection
If a HAZARDOUS SITUATION might develop by the incorrect
connection or replacement of a battery, verify the ME
Equipment is fitted with a means of preventing incorrect polarity
of connection. Review the manufacturers risk management file
for any risk analysis.
4.2 to 4.4
15.4.3.3
Protection against
overcharging
Does overcharging of any battery of ME Equipment result in an
unacceptable RISK, the design shall prevent overcharging?
Review the manufacturers risk management file for any risk
analysis.
4.2 to 4.4
15.4.3.4
Lithium batteries
Do lithium batteries used in ME EQUIPMENT that could
become a HAZARD comply with the requirements of IEC
60086-4? Review the manufacturers risk management file for
any risk analysis.
4.2 to 4.4
15.4.3.5
Excessive current
and voltage
protection
Has the manufacturer provided justification for the omission of
fuses or over-current releases in the risk management file?
If so, protection against fire caused by excessive currents is by
inspection of the design and the risk management file and no
additional testing is required.
4.2 to 6.5
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Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
15.4.4
Indicators
Are indicator lights provided on ME Equipment incorporating
non-luminous heaters to indicate that the heaters are
operational, if a HAZARDOUS SITUATION could exist unless it
is otherwise apparent to the operator from the normal operating
position? Review the manufacturers risk management file for
any risk analysis.
Are indicator lights provided on ME Equipment to indicate that
an output exists where an accidental or prolonged operation of
the output circuit could constitute a HAZARDOUS
SITUATION? Review the manufacturers risk management file
for any risk analysis.
4.2 to 4.4
15.4.5
Pre-set controls
Where applicable, has the manufacturer addressed the risk
associated with pre-set controls?
4.2 to 6.5
15.4.7.3 b
Entry of liquids
Has the manufacturer conducted risk analysis for foot operated
control devices during their risk management process?
If so, is the probability of occurrence of the intended normal
use in areas where liquids are likely to be found low enough
such that foot-operated control devices that contain electrical
circuits do not have to be classified IPX6 according to IEC
60529?
If so, then perform testing at the manufacturer’s lesser IPX_
rating. Note IPX1 is the minimum rating.
If not, then verify compliance to IPX6 classification.
4.2 to 4.4
Clause 16 – ME Systems
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
16.1
General
Requirements for
ME Systems
After installation or subsequent modification, does the ME
system result in an unacceptable risk?
Have hazards arising from combining various equipment to
constitute an ME system been considered?
Is the level of safety equivalent to ME system complying with
this standard IEC 60601-1 within the patient environment?
If the ME System is reconfigurable, have risk management
methods been used to determine which configurations
constitute the highest risks and which measures are needed to
ensure that the reconfiguration does not constitute an
unacceptable risk?
4.2 to 5
16.9.1
Connection
terminals and
connectors
Are the design and construction of electrical, hydraulic,
pneumatic and gas connection terminals and connectors such
that incorrect connection of accessible connectors, removable
without the use of a tool, can be prevented where a
HAZARDOUS SITUATION could otherwise exist? Review the
manufacturers risk management file for any risk analysis, risk
evaluation and risk control measures.
Are plugs for patient leads designed to prevent connection to
other outlets of the same ME System that are likely to be
located in the patient environment unless no hazardous
situation can result? Review the manufacturers risk
management file for any risk analysis, risk evaluation and risk
control measures.
4.2 to 6.5
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Clause 17 – Electromagnetic compatibility of MEE and MES
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
17
Electromagnetic
compatibility of
ME equipment
and ME systems
Does the risk management process address the risks
associated with the electromagnetic phenomena existing at the
locations where the ME equipment or ME System is intended to
be used as indicated in the accompanying documents?
Does the risk management process address the risks
associated with the introduction by the ME equipment or ME
system of electromagnetic phenomena into the environment
that might degrade the performance of other devices, electrical
equipment, and systems?
4.2 to 6.5
Notes:
Clauses 3.3a, 3.5e, and 7 shall be included in the complete RM file which has been addressed through clause 4.3.
Numbering above is inclusive as applicable. This document includes clauses from IEC 60601-1 which have guidance for
inspection requirements of the manufacturer’s risk management file, risk control measures and risk management
process. The document does not address other clauses from IEC 60601-1 which include key terms for example RISK
(with or without qualifying words such as unacceptable, acceptable and significant), HAZARD, HAZARDOUS
SITUATION. These clauses do not necessarily require the manufacturer to include them in their risk management
process.
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6.2 Application of ISO 14971:2007 in IEC 60601-1:2005 + A1:2012 product evaluation
IEC 60601-1:2005 + A1:2012 (Ed.3 + Am. 1) Medical electrical equipment, Part 1: General
requirements for basic safety & essential performance - Guidance for the application of ISO
14971:2007 (Ed.2)
Clause 4 – General requirements
IEC 60601-1
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
4.2.2
General
requirements for
RISK
MANAGEMENT
Compliance is checked by:
- inspection of the MANUFACTURER'S policy for
determining criteria for RISK acceptability;
- inspection of the RISK MANAGEMENT plan for the
particular ME EQUIPMENT or ME SYSTEM under
consideration; and
- confirming the MANUFACTURER has prepared a RISK
MANAGEMENT FILE containing the RISK
MANAGEMENT RECORDS and other documentation
required by this standard for the particular ME
EQUIPMENT or ME SYSTEM under consideration.
3.3,
3.5,
4.1 to 8
Does the manufacturer have a risk management process
according to ISO14971:2007 in place?
Was this process used for the device being considered?
If so, a limited number of more detailed questions can be
addressed at this point:
· Are all risk management procedures (that meet the
requirements of ISO14971:2007, including acceptability
criteria) developed and applied for the device considered
(clauses 3.3, 3.4, 3.5, 4 to 8 of ISO14971:2007)?
· Is there a risk management plan (including resources and
commitment) for the device considered (clause 3.4 of
ISO14971:2007)?
· Has the manufacturer established requirements for
maintaining a Risk management file (clause 3.5 of ISO
14971:2007)?
· Is the overall residual risk for the device considered
acceptable (clause 7 of ISO 14971:2007)?
· Has the manufacturer established requirements for creating
a Risk management report to document the review of Risk
management activities (clause 8 of ISO 14971:2007)?
NOTES:
The table shown above is a modified version of Table 4.2 from Section 6.1 of this document used when
applying IEC 60601-1:2005 + A1:2012 and ISO 14971:2007. For all other Risk management requirements in
IEC 60601-1:2005 + A1:2012, use the corresponding guidance from section 6.1 of this document for
completing the RM Tables in Revision H of the TRF. Where no RM Table exists in Revision H of the TRF, no
assessment of the Risk management file is required.
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IEC 60601-1:2005 + A1:2012 modified the Risk management requirements now summarized in Table 4.2.2
and removed the need to assess the Risk management file for many other clauses. No new Risk
management requirements were added above those already described in IEC 60601-1:2005..
Clauses 3.3, 3.4, 3.5, 7 and 8 shall be included in the complete RM file which has been addressed through
clause 4.3. Numbering above is inclusive as applicable. This document includes clauses from IEC 60601-1
which have guidance for inspection requirements of the manufacturer’s risk management file, risk control
measures and risk management process. The document does not address other clauses from IEC 60601-1
which include key terms for example RISK (with or without qualifying words such as unacceptable, acceptable
and significant), HAZARD, HAZARDOUS SITUATION. These clauses do not necessarily require the
manufacturer to include them in their risk management process.
6.3 IEC 60601-1-3:2008 / ISO 14971:2000
IEC 60601-1-3:2008 Collateral standard: Radiation Protection in Diagnostic X-Ray Equipment Guidance for the application of ISO 14971:2000
IEC 606011 Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
6.3.2
Reproducibility of
the RADIATION
output
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE determine the
reproducibility of the RADIATION output relative to fixed
LOADING FACTORS required for the INTENDED USE?
4.2 to 6.4
6.4.3
Indication of
LOADING
FACTORS and
MODES OF
OPERATION
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, has the Manufacturer determined the accuracy of the
LOADING FACTORS required for the INTENDED USE?
4.2 to 6.4
6.5
AUTOMATIC
CONTROL
SYSTEM
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE determine the
constancy of AUTOMATIC EXPOSURE CONTROLS required
for the INTENDED USE?
4.2 to 6.4
6.7.2
System
performance
Has the Manufacturer defined and specified metrics describing
imaging performance for the INTENDED USE?
4.2 to 6.6
6.7.3
Nominal focal spot
value
Has the Manufacturer defined The nominal focal spot values
of the X-RAY TUBE(s) FOCAL SPOTS in the EQUIPMENT
according to IEC 60336?
4.2
6.7.4
RADIATION
DETECTOR or XRAY IMAGE
RECEPTOR
If a RADIATION DETECTOR or X-RAY IMAGE RECEPTOR is
integrated in the X-RAY EQUIPMENT, has the Manufacturer
specified the contribution to the metrics of imaging
performance?
Is this contribution sufficient to ensure the efficient use of
RADIATION?
If no X-RAY IMAGE RECEPTOR is integrated in the system,
has the Manufacturer described in the ACCOMPANYING
DOCUMENTS examples of X-RAY IMAGE RECEPTOR types
or performance?
4.3 to 6.6
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ISO 14971
Clauses
7.2
Waveform of the XRAY TUBE
VOLTAGE
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, has the Manufacturer define the characteristics of The XRAY TUBE VOLTAGE waveform, taking in consideration:
•
the rising phase of the X-RAY TUBE VOLTAGE;
•
the falling phase of the X-RAY TUBE VOLTAGE; and
•
the shape and amplitude of the X-RAY TUBE VOLTAGE
RIPPLE.
which, in conjunction with the TOTAL FILTRATION in the
XRAY EQUIPMENT, results in an acceptable RADIATION
dose for the INTENDED USE?
4.2 to 6.4
8.1
Limitation of the
extent of the XRAY BEAM
(General)
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the risk management file consider all the risk
associated not to limit the RADIATION FIELD not contributing
to the formation of the image?
4.4 to 6.4
8.5.3
Correspondence
between X-RAY
FIELD and
EFFECTIVE
IMAGE
RECEPTION
AREA
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the Manufacturer identify and provide means to
adjust the X-RAY FIELD such that its position and size
correspond to the EFFECTIVE IMAGE RECEPTION AREA?
Is this means designed with an acceptable accuracy?
4.4 to 6.4
Note: For clause 4.4 and 5.0 of ISO 14971, see also 8.5.1.
9.1
FOCAL SPOT TO
SKIN DISTANCE
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, has the Manufacturer identified The FOCAL SPOT TO
SKIN DISTANCES in NORMAL USE sufficiently large to keep
the RADIATION dose to the PATIENT as low as reasonably
achievable?
Has the Manufacturer defined a minimum FOCAL SPOT TO
SKIN DISTANCE?
4.4 to 6.4
10.1
ATTENUATION of
the X-RAY BEAM
between the
PATIENT and the
X-RAY IMAGE
RECEPTOR
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, has the manufacturer designed the X-RAY EQUIPMENT
in such a way that the ATTENUATION of the X-RAY BEAM by
material interposed between the PATIENT and the X-RAY
IMAGE RECEPTOR is kept as low as reasonably achievable
in order to avoid unnecessarily high doses to the PATIENT
and, through STRAY RADIATION, to the OPERATOR.
Does the risk management file determine the values of
ATTENUATION EQUIVALENT and RADIATION
CONDITIONS for testing required for the INTENDED USE?
4.2 to 6.4
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Considerations for application of RM criteria
ISO 14971
Clauses
11
Protection against
RESIDUAL
RADIATION
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE evaluate the
RADIATION dose resulting from the RESIDUAL RADIATION:
•
for the PATIENT, relative to the RADIATION dose
resulting from the examination, and
•
for other persons, relative to the dose resulting from XRADIATION scattered off the PATIENT?
Does the Manufacturer identify the need to incorporate in the
X-RAY EQUIPMENT a PRIMARY PROTECTIVE
SHIELDING?
Is this PRIMARY PROTECTIVE SHIELDING taking into
account the RESIDUAL RADIATION which contribute
significantly to the RADIATION dose received by:
•
OPERATORS,
•
other persons present in the examination room during the
LOADING (e.g. parents holding a child, other PATIENTS
or personnel),
•
parts of the PATIENT other than from those being
currently imaged?
4.3 to 6.6
12.1
Protection against
LEAKAGE
RADIATION
Has the manufacturer addressed this risk by applying and
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE evaluate the
RADIATION dose resulting from the LEAKAGE RADIATION:
•
for the PATIENT, relative to the RADIATION dose
resulting from the examination, and
•
for other persons, relative to the dose resulting from XRADIATION scattered off the PATIENT?
Does the RISK MANAGEMENT FILE consider the LEAKAGE
RADIATION which contribute significantly to the RADIATION
dose received by:
•
OPERATORS,
•
other persons present in the examination room during the
LOADING (e.g. parents holding a child, other PATIENTS
or personnel),
•
parts of the PATIENT other than from those being
currently imaged?
4.2 to 6.6
12.2
Mounting of X-RAY
SOURCE
ASSEMBLIES and
X-RAY IMAGING
ARRANGEMENTS
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE included
exceptions to justify that the X-RAY SOURCE ASSEMBLIES
and/or the X-RAY IMAGE RECEPTOR need to be hand held
during LOADING in NORMAL USE?
4.2 to 6.6
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Considerations for application of RM criteria
ISO 14971
Clauses
13.2
Control of X-ray
equipment from a
protected area
Has the manufacturer addressed this risk by applying an
applicable particular standard?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE cover exceptions
related to the following control functions:
•
selection and control of MODES OF OPERATION;
•
selection of LOADING FACTORS;
•
actuation of the IRRADIATION SWITCH;
•
other necessary controls for the OPERATOR during
LOADING,
where the control functions are to be implemented from a
PROTECTED AREA after installation, for X-RAY EQUIPMENT
specified exclusively for examinations that do not need the
OPERATOR or staff to be close to the PATIENT during
NORMAL USE?
4.2 to 6.6
Supplementary information: See also 13.3
13.3
Protection by
distance
Has the manufacturer addressed this risk by applying an
applicable particular standard or some exception applies?
If yes, this requirement does not apply.
If no, does the RISK MANAGEMENT FILE determine, for the
INTENDED USE, the distance required and the RADIATION
dose resulting from the STRAY RADIATION?
Is this distance sufficiently long to protect operator?
4.2 to 6.6
Supplementary information: See also 13.2
6.4 IEC 60601-1-6:2010 / ISO 14971:2007 / IEC 62366:2007
When evaluating compliance with IEC 60601-1-6:2010, it is important to understand the relationships that
exist between this standard, IEC 60601-1:2005, IEC 62366:2007 and ISO 14971:2007.
Figure 1 below provides a graphical representation of this relationship. IEC 60601-1-6:2010 is a collateral
standard in the IEC 60601-1 series covering the requirements for the Usability Engineering Process. IEC
60601-1:2005 makes a normative reference to IEC 60601-1-6 for requirements related to usability. Currently,
IEC 60601-1-6:2010 links the IEC 62366:2007 which contains requirements for the usability engineering
process.
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Figure 1: Relationship between USABILITY (IEC 60601-1-6 & IEC 62366) and RISK MANAGEMENT (ISO
14971)
IEC 60601-1-6:2010 makes a normative reference to IEC 62366:2007 for the Usability Engineering Process
requirements: In turn, IEC 62366:2007 makes a normative reference to ISO 14971:2007 for the requirements
related to Risk Management.
When performing the usability engineering process and the risk management process there are deliverables
from each process that are used as inputs into the other process. Figure 1 indicates in which process these
deliverables are generated and which deliverables are necessary for completing the other process.
When complying with IEC 60601-1:2005, IEC 60601-1-6:2010, IEC 62366:2007 and ISO 14971:2007 are all
required to satisfy the requirements for the Usability Engineering Process.
IEC 60601-1-6:2010 Collateral standard: Usability
Guidance for the application of ISO 14971:2007 and IEC 62366:2007
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Considerations for application of RM criteria
ISO 14971
Clauses
4.2
(60601-16)
General
Requirements –
Conditions for
application to ME
EQUIPMENT
Compliance is confirmed through application of IEC 60601-16:2010, IEC 62366:2007 and ISO 14971:2007
Equipment provides adequate USABILITY such that RISKS
resulting from NORMAL USE and USE ERROR are considered
acceptable
Has the USABILITY ENGINEERING PROCESS adequately
addressed all RISKS associated with NORMAL USE and USE
ERROR?
3.2, 3.4d,
4-7
4.1.2
(62366)
RESIDUAL RISK
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
Has compliance with Clause 5.9 of IEC 62366:2007 been
demonstrated?
Has the USABILITY ENGINEERING PROCESS integrated all
elements of RISK MANAGEMENT as required by this standard?
Have all design changes related to USABILITY been reviewed
to determine if any new HAZARDS or HAZARDOUS
SITUATIONS have been generated?
Has the manufacture adequately addressed all risks related to
usability, and have all the risk been mitigated to an acceptable
level?
6.4
4.1.3
(62366)
Information for
SAFETY
Compliance is checked by inspection of the ACCOMPANYING
DOCUMENTS and the USABILITY ENGINEERING FILE
Has the MANUFACTURER identified any information for
SAFETY as a RISK CONTROL MEASURE?
•
If yes, has this information been subject to the USABILITY
ENGINEERING PROCESS to determine acceptable
USABILITY?
•
If yes, has this information been subject to the RISK
MANAGEMENT PROCESS when determining the
appropriate RISK CONTROL measure?
5, 6.2
4.3
(62366)
Scaling of the
USABILITY
ENGINEERING
effort
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
Has the MANFACTURER scaled the USABILITY
ENGINEERING PROCESS?
•
If yes, has the MANUFACTURER taken into account the
nature of the MEDICAL DEVICE, the intended USER and
the INTENDED USE?
•
If yes, does the RISK ANALYSIS indicate the scaling was
based on the significance of the modification?
4.2-4.4
5.3.1
(62366)
Identification of
characteristics
related to
SAFETY
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
When applying ISO 14971:2007, clause 4.2, has the
MANFACTURER identified all characteristics related to
SAFETY related to USABILITY (or poor USABILITY)?
Has the MANUFACTURER included the application
specification, USER PROFILE(s), and list of frequently used
functions as inputs?
4.2
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IEC 606011 Clauses
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Considerations for application of RM criteria
ISO 14971
Clauses
5.3.2
(62366)
Identification of
known or
foreseeable
HAZARDS and
HAZARDOUS
SITUATIONS
Compliance is checked by inspection of the USABILTY
ENGINEERING FILE
When applying ISO 14971:2007, Clause 4.3, has the
MANUFACTUER identified all known or foreseeable HAZARDS
and HAZARDOUS SITUATIONS related to USABILITY (or poor
USABILITY)?
Has the MANUFACTURER adequately identified reasonably
foreseeable sequences or combinations of events involving the
USER INTERFACE?
When identifying HAZARDS and HAZARDOUS SITUATIONS
related to USABLITY, has the MANUFACTURER considered
(used as inputs) the following:
•
Application specification, including the USER PROFILE(S)
•
Task related requirements (user)
•
Context of use
•
Known HAZARDS and HAZARDOUS SITUATIONS from
USER INTERFACES of similar MEDICAL DEVICES
•
USE SCENARIOS
•
Foreseeable USE ERROR(S)
•
A review of the USER INTERFACE
4.3
5.5
(62366)
USABILITY
SPECIFICATION
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
Does the USABILITY ENGINEERING FILE contain specific
criteria for determining the adequacy of RISK CONTROL
measures related to USABILITY?
Does the USABILITY SPECIFICATION included the following
minimum items:
•
Application specification
•
PRIMARY OPERATING FUNCTIONS
•
HAZARDS/HAZARDOUS SITUATIONS related to
USABILITY
•
Known and foreseeable USE ERRORS
At a minimum, does the USABILITY SPECIFICATION describe
the following:
•
USE SCENARIOS related to the PRIMARY OPERATING
FUNCTIONS (frequent USE SCENARIOS, reasonably
foreseeable worst case USE SCENARIOS)
•
USER INTERFACE requirements for the PRIMARY
OPERATING FUNCTIONS including those used as RISK
MITIGATIONS
•
Requirements for determining if the PRIMARY
OPERATING FUNCTIONS are easily recognized by the
USER
3.4 d),
4.3, 5,
6.2-6.4
5.6
(62366)
USABILITY
VALIDATION
plan
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
Does the plan for validation of the PRIMARY OPERATING
FUNCTIONS include the criteria for RISK acceptability
determined through ISO 14971:2007, clause 3.4 d) as
acceptance criteria?
3.4 d)
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ISO 14971
Clauses
5.9
(62366)
USABILITY
VALIDATION
Compliance is checked by inspection of the USABILITY
ENGINEERING FILE
If the criteria of the USABILITY VALIDATION plan have not
been met, and the MANUFACTURER has determined that
further improvement of the USER INTERFACE is not practical;
has the MANUFACTURER done the following:
•
Estimated RISKS arising from USABILITY problems
•
Gathered and reviewed data and literature to determine
that the medical benefit of the INTENDED USE outweighs
the RISKS arising from the USABILITY problems
•
Determined that all RISKS are acceptable?
4.4, 5,
6.4-6.5
6.5 IEC 60601-1-8:2006 / ISO 14971:2000
IEC 60601-1-8:2006 Collateral standard: General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical electrical systems
Guidance for the application of ISO 14971:2000
IEC 606011-8
Clauses
Subject
Considerations for application of RM criteria
ISO
14971
Clauses
4
Alarm System –
General
requirements
Compliance is checked by inspection of the risk management file.
As a means of risk control, has the manufacturer provided an alarm
system that is used to notify the operator that a hazardous situation can
exist?
•
If so, then an alarm system complying with this standard is used
for this purpose.
•
If not, continue with other risk management requirements.
Does the manufacturer’s risk assessment identify hazards to patients,
operators and other persons arising from the alarm system?
•
If so, verify that the resulting risk is an acceptable level before or
after risk control measures are implemented as applicable based
on the manufacturers criteria for acceptable risks.
•
If not, and the medical electrical equipment has an alarm system,
then this is an unacceptable result.
6.2-6.6
Compliance is checked by inspection of the risk management file.
Does the manufacturer’s risk management file include the assignment
of alarm priorities based on Table 1 or in accordance with relevant
particular standards?
•
If so, then verify by testing them accordingly.
•
If not, then this is an unacceptable result.
Review the manufacturer’s risk management file in regards to the
assignment of alarm condition priorities
4.2 – 5,
6.2 – 6.6
6.1.2
Alarm condition
priority
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IEC 606011-8
Clauses
Subject
Considerations for application of RM criteria
ISO
14971
Clauses
6.3.1
Generation of
Alarm Signals
Compliance is checked by inspection of the risk management file.
Does the manufacturer’s risk management file, risk assessment
considering the environment in which the ME Equipment is intended,
identify the need for additional alarm signals (audio, verbal, vibratory or
produced by other means)?
•
If so, then verify the implementation according to the
manufacturer’s risk management file;
•
If not implemented, then this is an unacceptable result, unless the
risk assessment shows no need for additional alarm signals.
4.2-5,
6.2-6.5
6.3.4
Characteristics of
verbal alarm
signals
Compliance is checked by inspection of the risk management file.
Does the manufacturer’s risk management file, consider the risks
associated with verbal alarm signals?
•
If so, verify the implementation of verbal alarm signals in
accordance with the risk management file;
•
If not, and the ME Equipment has provisions for verbal alarm
signals, then this is an unacceptable result;
•
If not, and the ME Equipment does not have provisions for verbal
alarm signals, then proceed to other risk management
requirements.
4.2-5,
6.2-6.6
6.8.3
Global indefinite
Alarm Signal
inactivation states
Compliance is checked by inspection of the risk management file.
Has the manufacturer’s risk management file, risk assessment,
considered the intended environment of use, and accepted the Alarm
System function of global Alarm Off or global Audio Off?
•
If so, follow the requirements of the standard.
•
If not, then this is an unacceptable result.
4.2-5
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6.6 IEC 60601-1-10:2007 / ISO 14971:2000
IEC 60601-1-10:2007 Collateral standard: Requirements for the development of physiologic
closed-loop controllers - Guidance for the application of ISO 14971:2000
IEC 606011-10
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
4
General
requirements
Compliance is checked by inspection of the risk
management file.
Has the risk analysis considered HAZARDS from a PCLC?
• If so, then they shall be included in the RISK
MANAGEMENT PROCESS.
• If not, then this is an unacceptable result.
4.3-4.4
6.1
Accuracy of
controls and
instruments and
protection against
hazardous outputs
- Usability
Compliance is checked by inspection of the risk
management file.
Has the indication over time not lead to an unacceptable
RISK?
• If so, then the indication over time may be omitted.
• If not, then the information indication over time shall be
indicated continuously or by OPERATOR action.
Have the presentation format and the choice between
indicating the information continuously or by OPERATOR
action based on the USABILITY ENGINEERING
PROCESS?
• If so, then they shall be included in the RISK
MANAGEMENT PROCESS.
• If not, then this is an unacceptable result.
4.3 – 4.4, 6.2
-6.3
See
USABILITY
ENGINEERING
FILE
assessment
per IEC
60601-1-6
8.2.1
RECORDS and
PROCESS scaling
Compliance is checked by inspection of the risk
management file.
Have the RECORDS and documents produced from
application of the PCLC development PROCESS been
established and maintained to provide evidence of
conformity to requirements of this collateral standard?
• If so, then they shall form part of the RISK
MANAGEMENT FILE
• If not, then this is an unacceptable result.
Have the results of the RISK ANALYSIS based on
significance of the modification of a PCLC design been
documented?
• If so, then the PCLC development PROCESS shall
include the scaling up or scaling down of that
modification.
• • If not, then this is an unacceptable result.
4.3-4.4
8.2.2.3
FALLBACK MODE
Compliance is checked by inspection of the risk
management file.
Has the MANUFACTURER specified all FALLBACK
MODES of the PCLCS?
• If so, then the FALLBACK MODE shall have no
unacceptable RISK.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
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8.2.2.5
Limitation of the
MANIPULATED
VARIABLE
Compliance is checked by inspection of the risk
management file.
If necessary, have the measures been taken or means
provided to eliminate, control, or decrease RISKS to
acceptable levels by controlling of the following?
– the range of the MANIPULATED VARIABLE;
– the integral over a period of time of the MANIPULATED
VARIABLE; or
– the rate of change of the MANIPULATED VARIABLE.
• If so, follow the requirements of the standard.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
8.2.2.6
Responses of the
PCLCS
Compliance is checked by inspection of the risk
management file.
If the PCLC changes its mode of operation, does the
PCLCS have a means of notifying and indicating to the
OPERATOR of its change in mode of operation?
• If so, the RISK ANALYSIS shall determine the choice
between an INFORMATION SIGNAL and an ALARM
CONDITION and its priority.
• If not, then this is an unacceptable result.
4.3-4.4, 5, 6.2
8.2.2.7
Range limitation of
PHYSIOLOGIC
VARIABLE
Compliance is checked by inspection of the risk
management file.
Does the PCLCS provide the means to monitor the value
of the PHYSIOLOGIC VARIABLE within its acceptable
range? Or limit the value of the MANIPULATED
VARIABLE, or CONTROLLER OUTPUT VARIABLE?
• If so, follow the requirements of the standard and if the
value of the PHYSIOLOGIC VARIABLE exceeds its
specified range, the PCLCS shall switch into a
FALLBACK MODE.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
8.2.3.1
General
Have measures been taken or means provided in the
PCLC to eliminate unacceptable RISK to the PATIENT that
could be caused by unfavourable response of the PCLCS
to DISTURBANCE VARIABLES including PATIENT
DISTURBANCE VARIABLES?
• If so, follow the requirements of the standard.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
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IEC 606011-10
Clauses
Subject
Considerations for application of RM criteria
ISO 14971
Clauses
8.2.3.2
Disturbance
analysis
Compliance is checked by inspection of the risk
management file.
Has the analysis of the effect of DISTURBANCE
VARIABLES on the PCLCS in NORMAL USE included the
following activities?
a) identification of foreseeable DISTURBANCE
VARIABLES;
b) characterization of those DISTURBANCE
VARIABLES;
c) analysis of the potential responses of the
PHYSIOLOGIC VARIABLE to those DISTURBANCE
VARIABLES in any mode of operation; and
d) analysis of the response of the PCLCS to those
DISTURBANCE VARIABLES in any mode of operation
• If so, follow the requirements of the standard.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
8.2.4
PCLC Verification
Compliance is checked by inspection of the risk
management file.
Has the PCLC undergone VERIFICATION against all Risk
Management specifications required by this collateral
standard?
• If so, follow the requirements of the standard.
• If not, then this is an unacceptable result.
6.3
8.2.5.1
PCLCS Validation
Compliance is checked by inspection of the risk
management file.
Has the Validation plan been based on the RISK
ANALYSIS and knowledge of the RESIDUAL RISKS?
• If so, follow the method selection requirements of the
standard.
• If not, then this is an unacceptable result.
4.3-4.4, 5,
6.2-6.5
6.7 IEC 60601-1-11:2010 / ISO 14971:2000
IEC 60601-1-11:2010 Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment Guidance for the application of ISO 14971:2000
IEC 606011-11
Clauses
Subject
Considerations for application of RM criteria
4.2.1
Environmental
conditions of
transport and
storage between
uses
Do the instructions for use state a more restricted range of
environmental transport and storage conditions between uses?
If yes, the range of environmental conditions shall be justified in the
Risk Management file.
4.2-4.4
4.2.2
Environmental
operating
conditions
Do the instructions for use state a more restricted range of
environmental operating conditions of the ME Equipment?
If yes, the range of environmental conditions shall be justified in the
Risk Management file
4.2-4.4
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ISO 14971
Clauses
© IEC – IECEE 2013
IEC 606011-11
Clauses
Subject
Considerations for application of RM criteria
7.4.1
Additional
requirements for
warning and
safety notices
For each warning and safety sign, the instructions for use shall
describe the nature of the HAZARD, likely consequences that could
occur if the advice is not followed, and the precautions for reducing
the RISK. Review the manufacturers risk management file for risk
analysis, risk evaluation and where necessary implementation of
risk control.
4.2-4.4, 5,
6.2-6.4
7.4.5
Additional
requirements for
operating
instructions
Where the instructions for use include a description of generally
known conditions in the HOME HEALTHCARE ENVIRONMENT
that can unacceptably affect the BASIC SAFETY and ESSENTIAL
PERFORMANCE of the ME EQUIPMENT and the steps that can be
taken by the LAY OPERATOR to identify and resolve these
conditions, review the manufacturers risk management file for risk
analysis, risk evaluation and implementation of risk control.
4.3-4.4, 5,
6.2-6.4
8.4
Additional
requirements for
interruption of the
power
supply/supply
mains to ME
Equipment and
ME System
When loss or failure of the SUPPLY MAINS or INTERNAL
ELECTRICAL POWER SOURCE would result in an unacceptable
risk, do the time or number of PROCEDURES remaining allow for
alternative life-supporting methods to be employed? If so, review
the manufacturers risk management file for risk analysis, risk
evaluation and where necessary implementation of risk control, as
well as whether an acceptable residual risk results.
4.2-4.4, 5,
6.2-6.7
9
Accuracy of
controls and
instruments and
protection against
hazardous
outputs
Have the RISKS associated with USABILITY in the HOME
HEALTHCARE ENVIRONMENT included consideration of all
factors identified by the Standard, placing particular emphasis on
the limited training of a LAY OPERATOR with respect to the ability
to intervene and maintain BASIC SAFETY and ESSENTIAL
PERFORMANCE? If so, review the manufacturer’s USABILITY
ENGINEERING FILE for risk analysis, risk evaluation and where
necessary implementation of risk control, as well as whether an
acceptable residual risk results.
See
Protection against
strangulation or
asphyxiation
Have means been provided to control the RISK of strangulation and
asphyxiation of the PATIENT and others to an acceptable level?
If so, review the manufacturers risk management file for risk
analysis, risk evaluation and where necessary implementation of
risk control, including whether other hazards may have been
generated.
4.3-4.4, 5,
6.2-6.6
11.0
ISO 14971
Clauses
USABILITY
ENGINEERING
FILE
assessment
per IEC
60601-16:2010
6.8 IEC 62304 Edition 1.0 2006-05
Medical device software –Software life cycle processes
When the requirements for software apply for the medical devices, 60601-1 requires compliance with
applicable clauses of IEC 62304 that makes normative reference to ISO 14971. In fact in the evaluation of a
device with respect to the requirements of 60601-1 which employs PEMS and PESS, a risk management
process is required to be followed.
According to IEC 60601-1, when the requirements in 14.2 to 14.13 apply, the requirements in subclause 4.3,
Clause 5, Clause 7, Clause 8 and Clause 9 of IEC 62304:2006 shall also apply to the development or
modification of software for PEMS and for each PESS.
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© IEC – IECEE 2013
IEC 62304 makes a normative reference to ISO 14971. However, some minor additional RISK
MANAGEMENT requirements are identified for software, especially in the area of identification of contributing
software factors related to HAZARDS. These requirements are summarized and captured in Clause 7 of IEC
62304 as the software RISK MANAGEMENT PROCESS.
The CBTL needs to ensure the manufacturer has taken into account the additional requirement for the
Software Risk Management.
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© IEC – IECEE 2013
Annex 1
ISO 14971:2000 Checklist (Informative)
Clause
Subject
Item
3.3 a)
Management
Responsibilities
a. Policy for determining
acceptable risk.
3.5 e)
Risk Management Plan
e. Evidence of risk
acceptability criteria.
4.1
Risk Analysis Procedure
Procedure for risk analysis.
4.2
Intended use/intended
purpose and/or
identification of
characteristics related to
the safety of the medical
device
Record of safety issue
analysis.
4.3
Identification of known or
foreseeable hazards
Record of hazard analysis
4.4
Estimation of the risk(s)
for each hazard
a. Definition of methods
used for estimating risks.
b. Description of method(s)
used.
c. Result of risk estimation
activities.
5.0
Risk evaluation
a. Result of risk evaluation
activities.
6.1
Risk reduction
Procedure for risk control
activities
6.2
Option analysis
Record of risk control option
analysis (including riskbenefit analysis, if
appropriate).
6.3
Implementation of risk
control measures
Inputs from risk management
activities
6.4
Residual risk evaluation
Final results of the residual
risk evaluation and, if
necessary, information
necessary to explain the
residual risk(s) in the
appropriate accompanying
documents
6.5
Risk-Benefit Analysis
Evidence as necessary.
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References
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© IEC – IECEE 2013
Clause
Subject
Item
References
6.6
Other generated hazards
Record of results of review of
all risk controls for to identify
if other hazards are
introduced by any risk control
measures and the associated
risk(s) assessment(s)
6.7
Completeness of risk
evaluation
Record of assessment to
assure that the risk(s) from all
identified hazards have been
evaluated
7
Overall residual risk
evaluation
Records of related meetings,
analysis, and overall results.
Note: The ANNEX 1 above is for ISO 14971 1st edition, if ISO 14971 2nd edition is used ANNEX 2 is applied.
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Annex 2
Clause
Subject
ISO 14971:2007 Checklist (Informative)
Item
References
3.2
Management
responsibilities
3.3
Management
Responsibilities
3.4
Risk
management
plan
3.5
Risk
management
file
Criteria for the establishment of a risk management
file providing traceability for each identified hazard
4.1
Risk Analysis
Procedure
Procedure for risk analysis.
4.2
Intended
use/intended
purpose and/or
identification of
characteristics
related to the
safety of the
medical device
Record of safety issue analysis.
4.3
Identification of
known or
foreseeable
hazards
Record of hazard analysis
4.4
Estimation of
the risk(s) for
each hazard
d. Definition of methods used for estimating risks.
e. Description of method(s) used.
f. Result of risk estimation activities.
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- provision of adequate resources
- assignment of qualified personnel
- Policy for determining acceptable risk
Persons performing work have appropriate knowledge
and experience
a)
b)
c)
d)
e)
Scope of risk management activities
Assignment of responsibilities and authorities
Requirements for review of activities
Evidence of risk acceptability criteria
Verification activities
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© IEC – IECEE 2013
Clause
Subject
Item
5.0
Risk evaluation
b. Result of risk evaluation activities.
6.1
Risk reduction
Procedure for risk control activities
6.2
Option analysis
Record of risk control option analysis (including riskbenefit analysis, if appropriate).
6.3
Implementation
of risk control
measures
Inputs from risk management activities
6.4
Residual risk
evaluation
Final results of the residual risk evaluation and, if
necessary, information necessary to explain the
residual risk(s) in the appropriate accompanying
documents
6.5
Risk-Benefit
Analysis
Evidence as necessary.
6.6
Other generated
hazards
Record of results of review of all risk controls for to
identify if other hazards are introduced by any risk
control measures and the associated risk(s)
assessment(s)
6.7
Completeness
of risk
evaluation
Record of assessment to assure that the risk(s) from
all identified hazards have been evaluated
7
Overall residual
risk evaluation
Records of related meetings, analysis, and overall
results.
8
Risk
management
report
Documented review of risk management process prior
to commercial distribution
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© IEC – IECEE 2013
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