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Standards [CURRENT]

BS EN ISO 10993-3

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2014-10-31

Standards [CURRENT]

ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Edition 2017-04

Standards [CURRENT]

ISO 15223-1

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Edition 2021-07

Packaging materials for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods.

Packaging materials for terminally sterilized medical devices - Part 7 : adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods.

Packaging materials for terminally sterilized medical devices - Part 6 : paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation - Requirements and test methods.

Standards [CURRENT]

ISO 18250-1

Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods
Edition 2018-12

Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals.

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Edition 2009-12-01

Standards [CURRENT]

BS EN 868-3

Packaging for terminally sterilized medical devices. Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). Requirements and test methods
Edition 2017-02-28

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