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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and l…

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…

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constitue…

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…

Microfluidics. Vocabulary.

Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity.

Biological evaluation of medical devices. Identification and quantification of degradation products from poly…

Biological evaluation of medical devices. Identification and quantification of degradation products from meta…

Biological evaluation of medical devices. Identification and quantification of degradation products from cera…

Biological evaluation of medical devices. Framework for identification and quantification of potential degrad…

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables.

Metallic materials. Fatigue testing. Axial force-controlled method.

Biological evaluation of medical devices. Tests for systemic toxicity.

Biological evaluation of medical devices. Tests for local effects after implantation.

Biological evaluation of medical devices. Ethylene oxide sterilization residuals.

Biological evaluation of medical devices. Requirements and general principles for the evaluation of biologica…

Biological evaluation of medical devices. Animal welfare requirements.

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials wit…

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…

Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products…

Overview ISO 10993-14:2001 is part of the ISO 10993 series on the biological evaluation of medical devices. It specifies in vitro methods to obtain, identify and quantify degradation products from ce…

Biological evaluation of medical devices — Part 23: Tests for irritation

Overview - ISO 10993-23:2021 (Tests for irritation) ISO 10993-23:2021 is part of the ISO 10993 series on the biological evaluation of medical devices. It specifies procedures to assess the potential…

Metals — Axial load fatigue testing

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement t…

Overview ISO/TR 10993-33:2015 - "Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3" is a Technical Report from ISO that provid…

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Overview ISO 10993-6:2026 is a critical international standard developed by ISO that outlines methodologies for the biological evaluation of medical devices, focusing on tests for local effects after…

Metallic materials — Fatigue testing — Axial force-controlled method

Overview ISO 1099:2017 - Metallic materials - Fatigue testing - Axial force-controlled method - defines conditions for conducting axial, constant‑amplitude, force‑controlled fatigue tests on metallic…

Animal (mammal) traps — Part 4: Methods for testing killing-trap systems used on land or underwater

Overview ISO 10990-4:1999 - "Animal (mammal) traps - Part 4: Methods for testing killing-trap systems used on land or underwater" defines standardized test methods for evaluating the performance of k…

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Overview ISO 10993-4:2017 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood provides general requirements and guidance for assessing how medical devi…

Agricultural tractors. Requirements for steering.

Tracked Changes. Biological evaluation of medical devices. Framework for identification and quantification of…

Tracked Changes. Biological evaluation of medical devices. Ethylene oxide sterilization residuals.

Tracked Changes. Biological evaluation of medical devices. Tests for local effects after implantation.

Biological evaluation of medical devices. Tests for in vitro cytotoxicity.

Biological evaluation of medical devices. Selection of tests for interactions with blood.

Biological evaluation of medical devices. Tests for irritation.

Biological evaluation of medical devices. Chemical characterization of medical device materials within a risk…

Biological evaluation of medical devices. Toxicological risk assessment of medical device constituents.

Tracked Changes. Biological evaluation of medical devices. Toxicological risk assessment of medical device co…

Tracked Changes. Biological evaluation of medical devices. Identification and quantification of degradation p…

Biological evaluation of medical devices. Sample preparation and reference materials.

Tracked changes. Biological evaluation of medical devices. Tests for skin sensitization.

Biological evaluation of medical devices. Tests for skin sensitization.

Tracked Changes. Biological evaluation of medical devices. Requirements and general principles for the evalua…

Tracked Changes. Microfluidics. Vocabulary.

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Overview ISO 10993-7:2026 is an international standard developed by ISO for the biological evaluation of medical devices, focusing specifically on Part 7: Ethylene oxide sterilization residuals. This…

Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for bio…

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products…

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…

Passenger vehicles — Side impact with deformable moving barrier — Full scale test

Micro process engineering — Vocabulary

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

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…

Agricultural tractors — Requirements for steering

Overview ISO 10998:2008 - "Agricultural tractors - Requirements for steering" specifies performance and safety requirements for both normal and emergency steering modes of agricultural tractors. It a…

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products…

Overview ISO 10993-13:2010 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices - defines requirements for ge…

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Overview ISO 10993-1:2018 - "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is the international framework for assessing biocompatibility…

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

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…

Biological evaluation of medical devices — Part 18: Chemical characterization of materials

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products…

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potenti…

Photography — Still-picture projectors — Determination of noise emissions

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of…

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…

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potenti…

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…