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Standards ISO - International Organization for Standardization - Page 197
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.
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ISO 10993-10:2021-ed.4.0
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Biological evaluation of medical devices — Part 10: Tests for skin sensitization
(Évaluation biologique des dispositifs médicaux — Partie 10: Essais de sensibilisation cutanée)
Standard published on 16.11.2021
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ISO 10993-11:2017-ed.3.0
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
(Évaluation biologique des dispositifs médicaux — Partie 11: Essais de toxicité systémique)
Standard published on 14.9.2017
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ISO 10993-12:2021-ed.5.0
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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
(Évaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence)
Standard published on 20.1.2021
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ISO 10993-12:2021-ed.5.0/Amd1:2025
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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
(Évaluation biologique des dispositifs médicaux — Partie 12: Préparation des échantillons et matériaux de référence — Amendement 1)
Change published on 13.8.2025
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ISO 10993-13:2010-ed.2.0
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
(Évaluation biologique des dispositifs médicaux — Partie 13: Identification et quantification de produits de dégradation de dispositifs médicaux a base de polymeres)
Standard published on 4.6.2010
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ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
(Évaluation biologique des dispositifs médicaux — Partie 14: Identification et quantification des produits de dégradation des céramiques)
Standard published on 22.11.2001
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ISO 10993-15:2019-ed.2.0
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Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
(Évaluation biologique des dispositifs médicaux — Partie 15: Identification et quantification des produits de dégradation issus des métaux et alliages)
Standard published on 26.11.2019
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ISO 10993-16:2017-ed.3.0
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Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
(Évaluation biologique des dispositifs médicaux — Partie 16: Conception des études toxicocinétiques des produits de dégradation et des substances relargables)
Standard published on 16.5.2017
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ISO 10993-17:2023-ed.2.0
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Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
(Évaluation biologique des dispositifs médicaux — Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux)
Standard published on 13.9.2023
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ISO 10993-17:2023-ed.2.0/Amd1:2025
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Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
(Évaluation biologique des dispositifs médicaux — Partie 17: Appréciation du risque toxicologique des constituants des dispositifs médicaux — Amendement 1)
Change published on 18.11.2025
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