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Standards [CURRENT]

BS EN 1641

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

Standards [CURRENT]

BS EN ISO 22442-2

Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
Edition 2020-12-14

Standards [CURRENT]

BS EN ISO 10993-16

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables
Edition 2018-01-09

Biological evaluation of medical devices - Part 22: guidance on nanomaterials
Edition 2017-08-23

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
Edition 2016-10-28

Biological evaluation of medical devices - Part 4: selection of tests for interactions with blood
Edition 2018-07-13

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: general requirements
Edition 2021-09-29

Biological evaluation of medical devices - Part 18: chemical characterization of medical device materials within a risk management process - Amendment 1: Determination of the uncertainty factor
Edition 2023-07-26

Standards [CURRENT]

ISO 20417

Medical devices - Information to be supplied by the manufacturer
Edition 2021-04

Draft standard

24/30479640 DC

BS EN 868-6 Packaging for terminally sterilized medical devices. Part 6: Paper for low temperature sterilization processes - Requirements and test methods
Edition 2024-04-11

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