NA 022

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

DIN EN ISO 20342-1 ; VDE 0750-2-52-1:2020-03 [CURRENT] references following documents:

Document number Edition Title
EUV 2017/745 2017-04-05 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More 
IEC 60601-2-52 2009-12 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds More 
ISO 11202 2010-05 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections More 
ISO 12952-1 2010-10 Textiles - Assessment of the ignitability of bedding items - Part 1: Ignition source: smouldering cigarette More 
ISO 12952-2 2010-10 Textiles - Assessment of the ignitability of bedding items - Part 2: Ignition source: match-flame equivalent More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 13850 2015-10 Safety of machinery - Emergency stop function - Principles for design More 
ISO 14708-1 2014-08 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO 17966 2016-01 Assistive products for personal hygiene that support users - Requirements and test methods More