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Standards [New]

DIN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024); German version EN ISO 16571:2024
Edition 2024-09

Draft standard

DIN EN 868-4

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German and English version prEN 868-4:2024
Edition 2024-05

Standards [New]

DIN EN ISO 17665

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
Edition 2024-09

Standards [CURRENT]

DIN EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
Edition 2018-09

Standards [CURRENT]

DIN EN 868-10

Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018
Edition 2019-03

Standards [CURRENT]

DIN EN ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023
Edition 2023-04

Standards [CURRENT]

DIN EN ISO 22442-2

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
Edition 2021-04

Standards [CURRENT]

DIN EN 868-8

Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
Edition 2019-03

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1 (ISO 15223-1:2021/DAM 1:2024); German and English version EN ISO 15223-1:2021/prA1:2024
Edition 2024-06

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024); German and English version EN ISO 10993-4:2017/prA1:2024
Edition 2024-04

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