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Standards [CURRENT]

ISO 20857

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Edition 2010-08

Standards [CURRENT]

BS EN ISO 9626

Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
Edition 2016-09-30

Standards [CURRENT]

BS EN ISO 10993-4

Biological evaluation of medical devices. Selection of tests for interactions with blood
Edition 2017-05-25

Standards [CURRENT]

BS EN 1639

Dentistry - Medical devices for dentistry - Instruments
Edition 2009-11-30

Standards [CURRENT]

ISO 18250-3

Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral applications
Edition 2018-06

Biological evaluation of medical devices - Part 2: Animal welfare requirements
Edition 2022-11-23

Draft standard

24/30479649 DC

BS EN 868-2 Packaging for terminally sterilized medical devices. Part 2: Sterilization wrap - Requirements and test methods
Edition 2024-04-11

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: general requirements

Regulation

EUV 2023/1194

Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council
Edition 2023-06-20

Medical devices - Guidance on the application of ISO 14971
Edition 2020-09-23

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