6.5 Elektrische Sicherheit, EMV und zugehörige Standards
1. IEC/EN 60601-1:2012: Medical Electrical Equipment, Part 1 General Requirements
for Safety
2. JIS T0601-1:2017: Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance
3. CAN/CSA-C22.2 Nr. 60601-1:14: Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
4. ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1
General Requirements for Safety
5. UL/IEC/EN 60950-1:2005: Information Technology Equipment - Safety - Part 1:
General Requirements
6. IEC60601-1-1:2000: General requirements for safety; Collateral standard: Safety
requirements for medical electrical systems
7. IEC60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements
for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements and tests
8. ISO 14971:2012 - Application of Risk Management to Medical Devices
9. Allgemeine Sicherheits- und Leistungsanforderungen der aktuellen VERORDNUNG
(EU) 2017/745
10. RICHTLINIE 2011/65/EU zur Beschränkung der Verwendung bestimmter gefährlicher
Stoffe in Elektro- und Elektronikgeräten (RoHS 2)
11. Richtlinie 2002/96/EG über Elektro- und Elektronik-Altgeräte (WEEE-Richtlinie)
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