2. Getting involved
3. Standards Committees
4. DKE

DKE German Commission for Electrical, Electronic & Information Technologies of DIN and VDE

Overview

This part of 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use. HEATING DEVICES intended to prewarm a bed are included in the scope of this document. This document does not apply to: - HEATING DEVICES intended for physiotherapy; - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21; - INFANT INCUBATORS; for information, see IEC 60601-2-19; - INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; - cooling devices. The standard differs from DIN EN IEC 60601-2-35 (VDE 0750-2-35):2022-10 as follows: a) update of the reference to the general standard IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance; b) adjustment of the reference in the clause Terms and definitions; c) clause "Controls" has been updated; d) clause "Electromagnetic compatibility - Requirements and tests" has been revised; e) adjustment of thermal conductivity values in Annex BB.1. The purpose of these particular requirements is to establish specific requirements for the basic safety and essential performance characteristics of heating devices with blankets, pads, or mattresses for warming in medical applications that reduce the hazards to patients and operators as much as possible, and to specify tests that can be used to verify compliance with these requirements.

Document: references other documents

Responsible national committee

DKE/UK 804.10 - Medizinische Geräte in der Pädiatrie