6.6 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012 (or IEC
60601-1: 2012 reprint): Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
2. ANSI/AAMI ES60601-1:2005+A2:2010+A1:2012: Medical Electrical Equipment - Part 1:
General Requirements For Basic Safety And Essential Performance
3. CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part 1: General
Requirements For Basic Safety And Essential Performance
4. IEC 60601-1-6:2010 Ed.3+A1: Medical Electrical Equipment - Part 1-6: General
Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
5. UL/IEC/EN 60950-1: Information Technology Equipment - Safety - Part 1: General
Requirements
6. IEC/EN 60601-1-1: General requirements for safety; Collateral standard: Safety
requirements for medical electrical systems
7. IEC/EN 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements
for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements and tests
8. ISO 14971 - Application of risk management to medical devices
9. Essential Requirements of the current European Union Medical Device Directive
93/42/EEC
10. RoHS (Restriction of the use of certain Hazardous Substance)
11. WEEE (Waste Electrical & Electronic Equipment) Legislation
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