Operation Manual MA 1
8100216 Rev. 5
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09/03/2023
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. 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
3. DIN/EN/ISO 14971:2012 - Application of risk management to medical devices
4. General Safety and Performance Requirements of the current REGULATION (EU)
2017/745
5. DIRECTIVE 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment (RoHS 2)
6. Directive 2002/96/EC on waste electrical and electronic equipment (WEEE)
