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Standards [CURRENT]

OENORM EN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Edition 2009-12-01

Draft standard [New]

OENORM EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)
Edition 2024-06-15

Standards [CURRENT]

OENORM EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Edition 2017-06-15

Draft standard [New]

OENORM EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)
Edition 2024-07-01

Standards [CURRENT]

OENORM 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) (consolidated version)
Edition 2022-10-01

Standards [CURRENT]

OENORM EN ISO 10993-9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Edition 2022-02-15

Standards [CURRENT]

OENORM EN ISO 10993-10

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Edition 2023-07-15

Standards [CURRENT]

OENORM EN ISO 10993-11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Edition 2018-10-15

Standards [CURRENT]

OENORM EN ISO 10993-12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Edition 2021-09-15

Standards [CURRENT]

OENORM EN ISO 10993-13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Edition 2010-10-01

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