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Draft standard

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

Standards [CURRENT]

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
Edition 2021-05

Draft standard [New]

DIN EN ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024); German and English version prEN ISO 10993-2:2024
Edition 2024-12

Standards [CURRENT]

DIN EN ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
Edition 2023-02

Standards [CURRENT]

DIN EN ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
Edition 2015-02

Standards [CURRENT]

DIN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017
Edition 2017-12

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

Standards [CURRENT]

DIN EN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009
Edition 2009-10

Draft standard

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024); German and English version prEN ISO 10993-6:2024
Edition 2024-06

Standards [CURRENT]

DIN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016); German version EN ISO 10993-6:2016
Edition 2017-09

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