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Found: 60+
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…
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 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 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 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 10993-12:2021/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 10993-17:2024 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 10993-17:2023 - "Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents" defines the process and requirements for carrying ou…
Overview 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 10993-15:2023 (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 10993-10:2023 (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 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 10993-12:2021, 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 - 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 - 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 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 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 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 10993-13:2010 (ISO 10993-13:2010) specifies requirements for identifying and quantifying chemical degradation products released from finished polymeric medical devices. It defines two…
Overview 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 10993-14:2009 (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 ISO 10993-18:2020/Amd 1:2022 is an important amendment to the international standard for the biological evaluation of medical devices, specifically addressing the chemical characterization o…
Overview ISO 10993-10:2021 - Biological evaluation of medical devices, Part 10: Tests for skin sensitization - defines procedures and interpretative criteria for assessing the potential of medical de…
Overview ISO 10993-11:2017 - "Biological evaluation of medical devices - Part 11: Tests for systemic toxicity" provides requirements and guidance for evaluating the potential of medical device materi…
Overview ISO 10993-17:2023/Amd 1:2025 is the latest amendment to the international standard focused on the biological evaluation of medical devices, specifically addressing toxicological risk assessm…
Overview ISO 10993-12:2021/Amd 1:2025 is an important amendment to the International Standard ISO 10993-12, which focuses on the biological evaluation of medical devices. Specifically, Part 12 addres…
BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances BS EN ISO 10993-17 specifies a method for the determination of allowable l…
Overview ISO 10993-17:2023 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - defines a standardized process for performing toxicolog…
Overview ISO 10993-16:2017 - Biological evaluation of medical devices, Part 16 provides principles for designing and performing toxicokinetic (TK) studies for degradation products and leachables from…
