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BS EN ISO 10993-18:2009 Biological evaluation of medical devices. Chemical characterization of materials BS EN ISO 10993-18 describes a framework for the identification of a material and the identifi…
1 Scope This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device tes…
Overview ISO 10993-18:2020 - "Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process" defines a structured framewor…
Overview ISO 10993-15:2019 - part of the ISO 10993 biological evaluation series - specifies general requirements for the design of in vitro tests to identify and quantify chemical degradation product…
1 Scope This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresp…
Overview EN ISO 10993-14:2009 (identical to ISO 10993-14:2001) is part of the ISO 10993 series on the biological evaluation of medical devices. It defines procedures to identify and quantify degradat…
Overview SIST EN ISO 10993-14:2009 lays out standardized methods for the biological evaluation of medical devices, specifically focusing on the identification and quantification of degradation produc…
Overview EN ISO 10993-13:2010 (ISO 10993-13:2010) specifies requirements for identifying and quantifying chemical degradation products released from finished polymeric medical devices. It defines two…
Overview EN ISO 10993-16:2017 (ISO 10993-16:2017) is part of the ISO 10993 series on the biological evaluation of medical devices. It provides principles for the design and conduct of toxicokinetic (…
Overview EN ISO 10993-11:2018 (ISO 10993-11:2017) - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" - specifies requirements and provides guidance on procedures to e…
Overview SIST EN ISO 10993-11:2018 (ISO 10993-11:2017) - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" - specifies requirements and provides guidance on procedures…
Overview - ISO 10993-18:2020 (EN ISO 10993-18:2020) ISO 10993-18:2020 defines a structured framework for the chemical characterization of medical device materials as part of a biological evaluation a…
Overview - ISO 10993-18:2020 (SIST EN ISO 10993-18:2020) ISO 10993-18:2020 defines a structured framework for the chemical characterization of medical device materials as part of a biological evaluat…
Overview EN ISO 10993-12:2021, titled Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, is a harmonized European Standard published by CEN and ISO. This…
Overview SIST EN ISO 10993-12:2021, titled Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, is a harmonized European Standard published by CEN and ISO.…
Overview EN ISO 10993-10:2023 (ISO 10993-10:2021) - Biological evaluation of medical devices - Part 10: Tests for skin sensitization - specifies procedures for assessing whether medical devices or th…
Overview EN ISO 10993-15:2023 (adoption of ISO 10993-15:2019) is part of the ISO 10993 series on the biological evaluation of medical devices. It provides guidance for the identification and quantifi…
Overview EN ISO 10993-18:2020/A1:2023 is the CEN-adopted amendment to ISO 10993-18 (Part 18 of the ISO 10993 series) that updates guidance on chemical characterization of medical device materials wit…
Overview EN ISO 10993-17:2023 - "Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents" defines the process and requirements for carrying ou…
Overview SIST EN ISO 10993-17:2024 is a fundamental international standard for the medical device industry, focusing on the toxicological risk assessment of medical device constituents. Published by…
Overview EN ISO 10993-12:2021/A1:2025 is an amendment to the established European Standard for the biological evaluation of medical devices, specifically focusing on sample preparation and reference…
Overview SIST EN ISO 10993-12:2021/A1:2025 is an amendment to the established European Standard for the biological evaluation of medical devices, specifically focusing on sample preparation and refer…
Overview EN ISO 10993-1:2025 - Biological evaluation of medical devices (Part 1) sets the requirements and general principles for assessing the biological safety of medical devices within a risk mana…
Overview EN ISO 10993-17:2023/A1:2025 (Amendment 1 to ISO 10993-17:2023) updates guidance for the toxicological risk assessment of medical device constituents. This amendment clarifies exposure calcu…
Overview SIST EN ISO 10993-17:2024/A1:2026 is the Slovenian adoption of Amendment 1 to the internationally recognized standard for medical device safety: ISO 10993-17, Part 17 - Toxicological risk as…
Overview SIST EN ISO 10993-1:2026 provides essential requirements and general principles for the biological evaluation of medical devices in the context of a risk management process. Developed by SIS…
