6.6 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1:2005+A1:2012: Medical Electrical Equipment, Part 1 General
Requirements for Safety
2. ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1
General Requirements for Safety
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 60950-1:2005: Information Technology Equipment - Safety - Part 1:
General Requirements
5. IEC 60601-1-1:2000: General requirements for safety; Collateral standard: Safety
requirements for medical electrical systems
6. IEC 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. ISO 14971:2012 - 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. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)
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