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Standards [CURRENT]

ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements
Edition 2022-11

Draft standard

ISO/DIS 10993-3

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
Edition 2025-04

Standards [CURRENT]

ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Edition 2014-10

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 10993-4 AMD 1

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
Edition 2025-01

Standards [CURRENT]

ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Edition 2009-06

Draft standard [New]

ISO/FDIS 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Edition 2025-10

Standards [CURRENT]

ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Edition 2016-12

Draft standard [New]

ISO/FDIS 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Edition 2025-11

Standards [CURRENT]

ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Edition 2008-10

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