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ISO (International Organization for Standardization) is the world’s largest producer of optional international standards. International standards determine current specifications of products, services and certified methods, helping to streamline the industry. As they are created on the basis of international agreement, they assist in overcoming barriers in international trade.
Biological evaluation of medical devices — Part 23: Tests for irritation
(Évaluation biologique des dispositifs médicaux — Partie 23: Essais d´irritation)
Standard published on 20.1.2021
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Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models
(Évaluation biologique des dispositifs médicaux — Partie 23: Essais d´irritation — Amendement 1: Modeles supplémentaires d´épiderme humain reconstruit in vitro)
Change published on 1.5.2025
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Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
(Évaluation biologique des dispositifs médicaux — Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction)
Standard published on 24.9.2014
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Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
(Évaluation biologique des dispositifs médicaux — Partie 33: Directives sur les essais pour évaluer la génotoxicité — Supplément a l´ISO 10993-3)
Standard published on 6.3.2015
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
(Évaluation biologique des dispositifs médicaux — Partie 4: Choix des essais pour les interactions avec le sang)
Standard published on 12.4.2017
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Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
(Évaluation biologique des dispositifs médicaux — Partie 4: Choix des essais pour les interactions avec le sang — Amendement 1)
Change published on 8.1.2025
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Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
(Évaluation biologique des dispositifs médicaux — Partie 5: Essais concernant la cytotoxicité in vitro)
Standard published on 20.5.2009
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Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
(Évaluation biologique des dispositifs médicaux — Partie 55: Étude interlaboratoire sur la cytotoxicité)
Standard published on 6.2.2023
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Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
(Évaluation biologique des dispositifs médicaux — Partie 6: Essais concernant les effets locaux apres implantation)
Standard published on 28.11.2016
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Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
(Évaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation a l´oxyde d´éthylene)
Standard published on 13.10.2008
Selected format:Latest update: 2025-09-22 (Number of items: 2 235 431)
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