Мы хотим включить аналитику посещений, чтобы понимать, что искать людям на сайте. Без вашего согласия счётчики не загружаются. Политика конфиденциальности
Найдено: 60+
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 10931:2005/Amd 1:2015 is an important international standard issued by the International Organization for Standardization (ISO) that focuses on plastics piping systems specifically desig…
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 10928:2025 (ISO 10928:2024) - Plastics piping systems - Glass‑reinforced thermosetting plastics (GRP) pipes and fittings - Methods for regression analysis and their use - specifies st…
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 ISO 10957:2021 - Information and documentation - International standard music number (ISMN) defines a global identifier for editions of notated music. The standard specifies the construction…
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 The SIST EN ISO 10943:2023 standard, titled Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023), issued by CEN, defines minimum requirements and test methods for indirect opht…
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 The EN ISO 10943:2023 standard, titled Ophthalmic instruments - Indirect ophthalmoscopes (ISO 10943:2023), issued by CEN, defines minimum requirements and test methods for indirect ophthalmo…
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 10942:2022 / ISO 10942:2022 specifies minimum requirements and test methods for hand‑held direct ophthalmoscopes, a category of ophthalmic instruments used for direct observation of t…
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 EN ISO 10961:2019 - Gas cylinders: Cylinder bundles - Design, manufacture, testing and inspection is the international / European standard that sets requirements for transportable cylinder b…
Overview EN ISO 10927:2018 - Plastics: Determination of the molecular mass and molecular mass distribution of polymer species by MALDI‑TOF‑MS - specifies a general, standardized relative method for m…
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 SIST EN ISO 10960:2018 specifies a standardized test method for assessing the resistance of rubber and plastics hoses to the damaging effects of atmospheric ozone under dynamic (flexing) con…
Overview EN ISO 10960:2018 (ISO 10960:2017) specifies a standardized method to assess the resistance of rubber and plastics hoses to the deleterious effects of atmospheric ozone under dynamic conditi…