Operation Manual MA 28
8506915 Rev. 3
39
15/11/2017
6.6 Electrical Safety, EMC and Associated Standards
1. IEC 60601-1:2012/ ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical
Equipment, Part 1 General Requirements for Safety
2. CAN/CSA-C22.2 No. 60601-1:2008: Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
3. UL/IEC/EN 60950-1:2005: Information Technology Equipment - Safety - Part 1:
General Requirements
4. IEC 60601-1-1:2000: General requirements for safety; Collateral standard: Safety
requirements for medical electrical systems
5. 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
6. DIN/EN/ISO 14971:2012 - Application of risk management to medical devices
7. Essential Requirements of the current European Union Medical Device Directive
93/42/EEC
8. DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS 2)
9. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)
Summary of Contents for MA 28
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