Safety Test Standards - Veridian Healthcare TENS 22-040 Manual De Instrucciones

SAFETY TEST STANDARDS

Medical Devices Directive 93/42/EEC
IEC 60601-1:2005+A1:2012/EN 60601-1:2006 Medical electrical equipment - Part 1:
General requirements for basic safety and essential performance
IEC60601-1-2 2014/EN60601-1-2 2014 Medical electrical equipment - Part 1-2:
General requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-2-10:2012/EN 60601-2-10:2000+A1:2001 Medical electrical equipment - Part
2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements
for basic safety and essential performance -- Collateral standard: Requirements for
medical electrical equipment and medical electrical systems used in the home health
care environment.
EN ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels,
labelling and information to be supplied -- Part 1: General requirements
EN 1041 Information supplied by the manufacturer with medical devices
IEC/60601-1-6/ EN 60601-1-6 Medical electrical equipment – Part1-6: General
requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-1-11/ EN 60601-1-11 Medical electrical equipment – Part 1-11: General
requirements for basic safety and essential performance – Collateral standard:
Requirements for medical electrical equipment and medical electrical systems used in
home health care environment
IEC 62304/ EN 62304 Medical device software - Software life-cycle processes
IEC 62366/ EN 62366 Medical devices - Application of usability engineering to medical
devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process
28 • ENGLISH