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Standards [CURRENT]

SN EN ISO 9626

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
Edition 2016-11

Standards [CURRENT]

SN 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)
Edition 2021-04

Standards [CURRENT]

SN EN ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Edition 2022-11

Standards [CURRENT]

SN EN ISO 10993-3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Edition 2014-12

Standards [CURRENT]

SN EN ISO 10993-4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Edition 2018-01

Standards [CURRENT]

SN EN ISO 10993-5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Edition 2009-11

Standards [CURRENT]

SN EN ISO 10993-6

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
Edition 2017-05

Standards [CURRENT]

SN EN ISO 10993-7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Edition 2008-12

Standards [CURRENT]

SN EN ISO 10993-7/AC

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008/Cor 1:2009); Corrigendum AC
Edition 2009-11

Standards [CURRENT]

SN EN ISO 10993-7/A1

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019); Amendment A1
Edition 2022-07

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