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ISO/TS 16775
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
Edition
2021-11
ISO/TS 11796
Biological evaluation of medical devices - Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
Edition
2023-07
ISO/TS 21387
Sterilization of medical devices - Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
Edition
2020-09
ISO/TS 19930
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10⁻⁶
Edition
2017-12
EUV 2020/1207
Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices
Edition
2020-08-19
EUV 2017/746
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
Edition
2017-04-05
EUV 2020/561
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
Edition
2020-04-23
EUV 2017/745
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
Edition
2017-04-05
