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1 Scope This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitizatio…
Overview ISO 10993-12:2021 sets internationally recognized requirements and guidance for the preparation of samples and the selection of reference materials for the biological evaluation of medical d…
Overview ISO 10993-1:2025 - Sixth edition - defines the requirements and general principles for the biological evaluation (biocompatibility evaluation) of medical devices within an ISO 14971 risk man…
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 10993-4:2017/Amd 1:2025 is the latest amendment to the international standard for the biological evaluation of medical devices, specifically focusing on the selection of tests for intera…
Overview ISO 10993-23:2021/Amd 1:2025 is an important amendment to the international standard for the biological evaluation of medical devices, specifically focusing on Part 23: Tests for irritation.…
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…
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 10993-3:2014 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - provides strategies and test-selection guidance for…
Overview ISO 10993-7:2008/Amd 1:2019 is an important amendment to the international standard focused on the biological evaluation of medical devices, specifically addressing ethylene oxide (EO) steri…
Overview ISO 10993-5:2009, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity," specifies methods to assess the in vitro cytotoxicity of medical devices and materials…
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 10993-10:2021 - 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 10993-18:2020/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 10993-2:2022 - "Biological evaluation of medical devices - Part 2: Animal welfare requirements" is the third edition (2022) in the ISO 10993 series. This standard specifies minimum anima…
Overview ISO 10993-3:2026 is the international standard that defines strategies for the biological evaluation of medical devices, focusing on four critical biological risks: genotoxicity, carcinogeni…
Overview ISO 10993-9:2019 - "Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products" provides a systematic framework for…
1 Scope This part of ISO 10993 specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the…
Overview ISO 10993-7:2008 - "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals" defines how to assess and control residual ethylene oxide (EO) and ethylene chl…
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…
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 EN ISO 10993-23:2021/A1:2025 is an amendment to ISO 10993-23:2021 - the part of the ISO 10993 series that specifies tests for irritation as part of the biological evaluation of medical devic…
Overview EN ISO 10993-5:2009/A11:2025 is a CEN amendment to the international standard for the biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Published March 2025…
Overview EN ISO 10993-4:2017/A1:2025 is the CEN-endorsed amendment to ISO 10993‑4 (Part 4 of the ISO 10993 series) that updates guidance for the biological evaluation of medical devices with respect…
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 EN ISO 10993-2:2022 - Biological evaluation of medical devices: Part 2: Animal welfare requirements (ISO 10993-2:2022) specifies minimum requirements to ensure and demonstrate humane care fo…
Overview EN ISO 10993-9:2021 (ISO 10993-9:2019) - "Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products" provides a str…
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 SIST EN ISO 10993-23:2021 - "Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)" defines procedures to assess a medical device’s potential to cause…
Overview EN ISO 10993-23:2021 - "Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)" defines procedures to assess a medical device’s potential to cause irrit…
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 (…
