German version EN 60601-1:2006/A13:2024 Class/Status:
Standard,
valid
Released: 2025-03
VDE Art. No.: 0701581
Note: You can pre-order this document (delivery subject to availability). Valid from 2025-03-01.
IEC 60601-1 and applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems connected to a supply network intended for the diagnosis, treatment or monitoring of a patient as specified by the manufacturer. This standard specifies general requirements for the safety, including the essential performance characteristics, of medical electrical equipment and serves as the basis for the safety requirements of special specifications. A review by the HAS Consultant in March 2023 showed insufficient compliance with Regulation (EU) 2017/745 of the European Parliament. CLC TC62 developed solutions and the necessary Annex ZZ that led to this A13.
This Document is related to the following Topics (in bold):
Normgerechte Stromversorgung und fachgerechte Überprüfung medizinischer elektrischer Geräte; DIN VDE 0100-100, DIN VDE 0100-410, DIN VDE 0100- 710, DIN IEC/TS 60479-1 (VDE V 0140-479-1), DIN VDE 0701-0702, DIN EN 60601-1 (VDE 0750-1), DIN EN 61140 (VDE 0140-1), DIN EN 61557-8 (VDE 0413-8), DIN EN 61557-9 (VDE 0413-9), DIN EN 62353 (VDE 0751-1) VDE-Schriftenreihe – Normen verständlich, Band 117
2018, 187 pages, Din A5, Broschur
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