1
Introduction
Standards applied
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Maquet Orchide
IFU 04661 EN 02
1.10 Standards applied
The device complies with the safety requirements of the following standards and directives:
Standards Year Title
Directive 93/42/EEC 1993 Medical devices directive (Annex VII)
Directive 2014/53/EU 2014 Radio equipment directive
IEC 60601-1+A1
EN 60601-1+A1
2012
2013
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
ANSI/AAMI
ES60601-1+A1
2005 +
2012
UL/cUL rating concerning electric shock, mechanical haz-
ards and fire risks.
CSA CAN/CSA-C22.2
NO. 60601-1
2014 Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance (standard IEC
60601-1+A1:2012, with specific requirements for Canada)
IEC 60601-1-2
EN 60601-1-2
2014
2015
Medical electrical equipment – Part 1-2: General require-
ments for basic safety and essential performance – Collat-
eral standard: Electromagnetic disturbances – Requirements
and tests
IEC 60601-1-6
EN 60601-1-6+A1
2010
2010 +
2013
Medical electrical equipment – Part 1-6: General require-
ments for basic safety and essential performance – Collat-
eral standard: Usability
IEC 62304
EN 62304/AC
2006
2008
Medical device software – Software life cycle processes
IEC 62311
EN 62311
2007
2008
Assessment of electronic and electrical equipment related to
human exposure restrictions for electromagnetic fields (0 Hz
– 300 GHz)
IEC 62366-1
EN 62366-1
2015
2015
Medical devices – Application of usability engineering to
medical devices
FCC Part 15 2008 Radio frequency device
Tab.4: Compliance with product standards
Quality management:
Standards Year Title
EN ISO 13485
ISO 13485
2016
2016
Medical devices – Quality management systems – Require-
ments for regulatory purposes
EN ISO 14971
ISO 14971
2012
2007
Medical devices – Application of risk management to med-
ical devices
Tab.5: Compliance with quality management standards
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