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ISO 10993-23
Biological evaluation of medical devices - Part 23: Tests for irritation
Edition
2021-01
NF S98-107-2 ; NF EN 556-2:2015-10-23
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices
Edition
2015-10-23
NF S98-107-1 ; NF EN 556-1:2024-07-03
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Edition
2024-07-03
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
PD CEN/TR 15133
Nomenclature. Collective terms and codes for groups of medical devices
Edition
2005-12-12
PD CEN ISO/TR 24971
Medical devices. Guidance on the application of ISO 14971
Edition
2020-06-19
NF S99-211 ; NF EN ISO 14971:2019-12-18
Medical devices - Application of risk management to medical devices
Edition
2019-12-18
NF S99-211/A11 ; NF EN ISO 14971/A11:2021-12-08
Medical devices - Application of risk management to medical devices
Edition
2021-12-08
ISO 13019
Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
Edition
2018-06
BS EN ISO 10993-18+A1
Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk management process
Edition
2020-06-01