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Standards [CURRENT]

ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation
Edition 2021-01

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices
Edition 2015-10-23

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Edition 2024-07-03

Regulation

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

Standards [CURRENT]

PD CEN/TR 15133

Nomenclature. Collective terms and codes for groups of medical devices
Edition 2005-12-12

Standards [CURRENT]

PD CEN ISO/TR 24971

Medical devices. Guidance on the application of ISO 14971
Edition 2020-06-19

Medical devices - Application of risk management to medical devices
Edition 2019-12-18

Medical devices - Application of risk management to medical devices
Edition 2021-12-08

Standards [CURRENT]

ISO 13019

Tissue-engineered medical products - Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
Edition 2018-06

Standards [CURRENT]

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

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