Riester RVS-100 Manual Del Usuario página 79

Appendix E Applicable Standards
MDD 93/42/EEC Council Directive 93/42/EEC
IEC 60601-­1:2005 + Medical electrical equipment -­-­ Part 1:
A1:2012 General requirements for safety
IEC 60601-­1-­2:2007 Medical electrical equipment –Part 1-­
2:General requirements for basic safety
and essential performance –Collateral
standard: Electromagnetic compatibility –
Requirements and tests
IEC 60601-­1-­6:2010 Medical electrical equipment –Part 1-­6:
General requirements for basic safety and
essential performance –Collateral standard:
Usability
IEC60601-­1-­ Medical electrical equipment –Part 1-­
8:2006+A1:2012 8:General requirements for basic safety
and essential performance –Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
IEC 62366:2007 Medical devices – Application of usability
engineering to medical devices
IEC 62304:2006 Medical device software –Software life
cycle processes
EN ISO 14971: 2012 Medical devices -­ Application of risk
management to medical devices
ISO 10993-­1:2009 Biological evaluation of medical devices—
Part 1：Evaluation and testing
IEC 60601-­2-­49: Part 2-­49: Particular requirements for the
2011 safety of multifunction patient monitoring
equipment
IEC 80601-­2-­ Part 2-­30: Particular requirements for the
30:2013 safety, including essential performance, of
automatic cycling non-­invasive blood
pressure monitoring equipment
ISO 80601-­2-­ Medical electrical equipment —Part 2-­
56:2009 56:Particular requirements for basic safety
and essential performance of clinical
thermometers for body temperature
measurement
ISO 80601-­2-­ Medical electrical equipment —Part 2-­
61:2011 61:Particular requirements for basic safety
and essential performance of pulse
oximeter equipment
ISO 15223.1:2012 Medical devices — Symbols to be used
with medical device labels, labelling and
information to be supplied
EN 1041:2008 Information Supplied by the Manufacturer
with Medical Device.
IEC 60825-­1:2007 Safety of laser products –Part 1:Equipment
classification and requirements
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