declaration of conformity
Delta Electronics, Inc
Declaration of Conformity
Ref No: MPBU-TW-201207044
Manufacturer name: Delta Electronics, Inc.
Add: 3 Tungyuan Road, Chungli Industrial Zone, Taoyuan County 32063, Taiwan
Tel: 886- 3- 4526107
Fax: 886 -3- 4527314
Is herewith confirmed the following equipment
Product:
AC/DC MEDICAL ADAPTER
Type Designation:
1. MDS-040APS12 B
2. MDS-040APS15 B
3. MDS-040APS18 B
Input Rating: 100-250Vac, 1-0.5 A, 50-60Hz
Output rating:
1. 12Vdc/3.33A
2. 15Vdc/2.67A
3. 18Vdc/2.22A
Comply with the following directives and requirements set out in the Council Directive on the
Approximation for the Laws of the Member States
Low Voltage Directive 2006/95/EC
EN 60950-1: 2006+A11: 2009+A1: 2010+A12: 2011 (Report No
EN 60065: 2002+A1: 2006+A11: 2008+A2: 2010 (Report No
)
)
MDD Directive 93/42/EEC
SAFETY: Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00)
(Report No: 11030014 001)
EN 60601-1: 2006
EMC: Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04)
(Report No: CE120906D12)
EN 60601-1-2: 2007
CISPR 11:2009+A1:2010 (Group I, Class B)
IEC 61000-3-2: 2005+A1:2008+A2:2009
IEC 61000-3-3: 2008
IEC 61000-4-2: 2008: Edition 2.0
IEC 61000-4-3: 2010: Edition 3.2
IEC 61000-4-4: 2012: Edition 3.0
IEC 61000-4-5: 2005: Edition 2.0
Page 1 of 2
Delta Electronics, Inc
IEC 61000-4-6: 2008: Edition 3.0
IEC 61000-4-8: 2009: Edition 2.0
IEC 61000-4-11: 2004: Edition 2.0
EMC Directive 2004/108/EC
EN 55022: 2010 Class B
EN 55013: 2001/A1: 2003/A2: 2006
EN 61000-3-2: 2006+A1:2009+A2:2009
EN 61000-3-3: 2008
EN 55024: 2010
EN 55020: 2007
IEC 61000-4-2: 2008: Edition 2.0
IEC 61000-4-3: 2010: Edition 3.2
IEC 61000-4-4: 2012: Edition 3.0
IEC 61000-4-5: 2005: Edition 2.0
IEC 61000-4-6: 2008: Edition 3.0
IEC 61000-4-8: 2009: Edition 2.0
IEC 61000-4-11: 2004: Edition 2.0
(Report No
)
WEEE Directive 2002/96/EC (Report No
)
RoHS Directive 2011/65/EU (Issue No:20120914)
Commission Regulation (EC) No 278/2009, ErP Directive 2009/125/EC
Annex I-(a);
Annex I-(b) (Report No
)
Responsible for marking this declaration is the:
Manufacturer
Authorized representative established within the EU (if applicable)
Company name:
Company address:
Person responsible for making this declaration
Name, Surname: Boyang Liao
Title: Senior Engineer, Regulatory & Reliability Engineering
Place: Taiwan
Date: 2012/09/19
Signature:
Page 2 of 2
Delta Electronics, Inc
Declaration of Conformity
Ref No: MPBU-TW-201209058
Manufacturer name: Delta Electronics, Inc.
Add: 3 Tungyuan Road, Chungli Industrial Zone, Taoyuan County 32063, Taiwan
Tel: 886- 3- 4526107
Fax: 886 -3- 4527314
Is herewith confirmed the following equipment
Product: Switching Power Supply
Type Designation:
1. MDS-040APS24 B
Input Rating: 100-250Vac, 1-0.5 A, 50-60Hz
Output rating:
1. 24Vdc/1.66A
Comply with the following directives and requirements set out in the Council Directive on the
Approximation for the Laws of the Member States
Low Voltage Directive 2006/95/EC
EN 60950-1: 2006+A11: 2009+A1: 2010+A12: 2011 (Report No
EN 60065: 2002+A1: 2006+A11: 2008+A2: 2010 (Report No
)
)
MDD Directive 93/42/EEC
SAFETY: Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00)
(Report No: 11030185 002)
EN 60601-1: 2006
EMC: Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04)
(Report No: CE120906D12A)
EN 60601-1-2: 2007
CISPR 11:2009+A1:2010 (Group I, Class B)
IEC 61000-3-2: 2005+A1:2008+A2:2009
IEC 61000-3-3: 2008
IEC 61000-4-2: 2008: Edition 2.0
IEC 61000-4-3: 2010: Edition 3.2
IEC 61000-4-4: 2012: Edition 3.0
IEC 61000-4-5: 2005: Edition 2.0
IEC 61000-4-6: 2008: Edition 3.0
IEC 61000-4-8: 2009: Edition 2.0
IEC 61000-4-11: 2004: Edition 2.0
Page 1 of 2
Delta Electronics, Inc
EMC Directive 2004/108/EC
EN 55022: 2010 Class B
EN 55013: 2001/A1: 2003/A2: 2006
EN 61000-3-2: 2006+A1:2009+A2:2009
EN 61000-3-3: 2008
EN 55024: 2010
EN 55020: 2007
IEC 61000-4-2: 2008: Edition 2.0
IEC 61000-4-3: 2010: Edition 3.2
IEC 61000-4-4: 2012: Edition 3.0
IEC 61000-4-5: 2005: Edition 2.0
IEC 61000-4-6: 2008: Edition 3.0
IEC 61000-4-8: 2009: Edition 2.0
IEC 61000-4-11: 2004: Edition 2.0
(Report No
)
WEEE Directive 2002/96/EC (Report No
)
RoHS Directive 2011/65/EU (Issue No:20121123)
Commission Regulation (EC) No 278/2009, ErP Directive 2009/125/EC
Annex I-(a);
Annex I-(b) (Report No
)
Responsible for marking this declaration is the:
Manufacturer
Authorized representative established within the EU (if applicable)
Company name:
Company address:
Person responsible for making this declaration
Name, Surname: Vicky Chen
Title: Senior Engineer, Regulatory & Reliability Engineering
Place: Taiwan
Date: 2012/12/04
Signature:
Page 2 of 2
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