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Technical rule [CURRENT]

API TR 410

Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells Exposed to Tertiary Amyl Methyl Ether (TAME)
Edition 1996-12

Technical rule [CURRENT]

API TR 411

Chinese Hamster Ovary (CHO)/HGPRT Mutation Assay of Tertiary Amyl Methyl Ether (TAME)
Edition 1996-12

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 21427-2

Water quality - Evaluation of genotoxicity by measurement of the induction of micronuclei - Part 2: Mixed population method using the cell line V79 (ISO 21427-2:2006); German version EN ISO 21427-2:2009
Edition 2009-08

Standards [CURRENT]

DIN EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007
Edition 2008-03

Standards [CURRENT]

DIN EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
Edition 2021-08

Standards [CURRENT]

DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
Edition 2024-02

Standards [CURRENT]

DIN EN ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021); German version EN ISO 10993-23:2021
Edition 2021-10

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

Standards [CURRENT]

DIN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
Edition 2022-09

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