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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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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
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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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from 151.90 EUR VAT included

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Standard [CURRENT] 2018-09

DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
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from 129.30 EUR VAT included

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Standard [CURRENT] 2023-07

DIN EN ISO 10993-15:2023-07
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019); German version EN ISO 10993-15:2023
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Standard [NEW] 2024-02

DIN EN ISO 10993-17:2024-02
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
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