6.6 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1: 2012: Medical Electrical Equipment, Part 1 General Requirements
for Safety and Essential Performance
2. AAMI ES60601-1:2005+A2+A1: Medical Electrical Equipment, Part 1 General
Requirements for Safety and Essent ial Performance
3. CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment, Part 1 General
Requirements for Basic Safety and Essential Performance
4. UL/IEC/EN 60950-1: Information Technology Equipment - Safety - Part 1: General
Requirements
5. IEC/EN 60601-1-1 General requirements for safety; Collateral standard: Safety
requirements for medical electrical systems
6. 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
7. DIN/EN/ISO 14971 - Application of risk management to medical devices
8. General Safety and Performance Requirements of the current REGULATION (EU)
2017/745
9. DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS 2)
10. Legislation Directive 2002/96/EC on waste electrical and electronic equipment
(WEEE)
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