DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE
Medical electrical equipment - Part 1: General requirements for safety
Abstract
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.
Begin
2024-06-25
Planned document number
DIN EN 60601-1/A13
Project number
02232375
Responsible national committee
DKE/UK 811.1 - Überarbeitung und Anpassung der allgemeinen Bestimmungen
