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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 10993-2:2022 - "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 10993-18:2020/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 10998:2008/Amd 1:2014 is an important amendment to the International Standard ISO 10998:2008, titled Agricultural tractors - Requirements for steering. Developed by the ISO Technical Com…
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 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 10991:2023 / ISO 10991:2023 - Microfluidics - Vocabulary defines standard terms and definitions used in micro process engineering and microfluidics. This second edition (approved Sept…
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 (…
Overview SIST EN ISO 10993-4:2018 (ISO 10993-4:2017) - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - specifies general requirements for evaluatin…
Overview EN ISO 10993-4:2017 - Biological evaluation of medical devices: Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) sets out general requirements and principles for eva…
Overview EN ISO 10993-3:2014 (adopted by CEN as EN ISO 10993-3:2014) is part of the ISO 10993 series for the biological evaluation of medical devices. It specifies strategies for risk estimation, sel…
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 10993-5:2009 (ISO 10993-5:2009) - "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity" - specifies in vitro test methods to assess the cytotoxic potent…
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 10993-7:2008/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 10993-6:2016 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation specifies standardized test methods to assess the local tissue response to im…
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…