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 require-
ments 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 healthcare 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 healthcare 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
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Summary of Contents for TD3 Series
Page 1: ...TD3 Series...
