Elektrische Sicherheit, Emv Und Zugehörige Standards - Maico MA 25 Benutzerhandbuch

6.6 Elektrische Sicherheit, EMV und zugehörige 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 Nr. 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
IEC 60601-1-1:2000: General requirements for safety; Collateral standard: Safety
5.
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. DIN/EN/ISO 14971 - Application of risk management to medical devices
8. Allgemeine Sicherheits-
VERORDNUNG (EU) 2017/745
9. RICHTLINIE 2011/65/EU zur Beschränkung der Verwendung bestimmter
gefährlicher Stoffe in Elektro- und Elektronikgeräten (RoHS 2)
10. Richtlinie 2002/96/EC über Elektro- und Elektronik-Altgeräte (WEEE)
8513010 Rev. 2
Benutzerhandbuch MA 25/MA 25e
und Leistungsanforderungen
38
MA 27/MA 27e
der aktuellen
26/10/2021