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60.60 Standard published Mar 28, 2018
CEN/CENELEC
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
European Norm
03.100.70 Management systems | 11.040.01 Medical equipment in general
Legislation related to this standard
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Harmonized/SupportingRegulation (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
Harmonized/Supporting
PUBLISHED
EN ISO 13485:2016/AC:2018
60.60
Standard published
Mar 28, 2018