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DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 10993-17 [New] references following documents:

Document number Edition Title
ISO 10993-18 2020-01 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices More 
ISO/TS 21726 2019-02 Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents More 
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