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Standards Worldwide
Standards Worldwide
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Medizintechnik

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Draft standard 2024-07

DIN EN ISO 10993-1:2024-07 - Draft
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

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Standard [CURRENT] 2021-05

DIN EN ISO 10993-1:2021-05
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

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Standard [CURRENT] 2023-02

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

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Draft standard 2024-04

DIN EN ISO 10993-4/A1:2024-04 - Draft
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

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Standard [CURRENT] 2009-10

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

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Draft standard 2024-06

DIN EN ISO 10993-6:2024-06 - Draft
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

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Standard [CURRENT] 2017-09

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

This standard DIN EN ISO 10993-6 has been adopted from the work of Technical Committee ISO/TC 194 "Biological and clinical evaluation of medical devices". It specifies test methods for the ...

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Draft standard 2024-08

DIN EN ISO 10993-7:2024-08 - Draft
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024); German and English version prEN ISO 10993-7:2024

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Standard [CURRENT] 2022-09

DIN EN ISO 10993-7:2022-09
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

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Standard [CURRENT] 2023-04

DIN EN ISO 10993-10:2023-04
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023

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