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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…

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.

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…

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…

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…

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…

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…

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…

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…

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…

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:20…

Overview EN ISO 10993-6:2026 - Biological evaluation of medical devices – Part 6: Tests for local effects after implantation – is an internationally recognized standard developed by CEN and ISO. This…

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)

Overview EN ISO 10993-7:2026 is an internationally recognized standard developed by CEN, defining requirements for the biological evaluation of medical devices specifically with regards to residuals…

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:20…

Overview SIST EN ISO 10993-6:2026 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation - provides internationally recognized requirements for evaluating the…

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026)

Overview SIST EN ISO 10993-7:2026 outlines requirements for the biological evaluation of medical devices, specifically addressing the management of residual ethylene oxide (EO) and ethylene chlorohyd…

Biological evaluation of medical devices - Identification and quantification of degradation products from met…

1 Scope This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresp…

Biological evaluation of medical devices - Animal welfare requirements

1 Scope This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in…

Biological evaluation of medical devices - Selection and qualification of reference materials for biological…

Biological evaluation of medical devices - Chemical characterization of materials

BS EN ISO 10993-18:2009 Biological evaluation of medical devices. Chemical characterization of materials BS EN ISO 10993-18 describes a framework for the identification of a material and the identifi…

Biological evaluation of medical devices - Tests for irritation and skin sensitization

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…

Biological evaluation of medical devices - Ethylene oxide sterilization residuals

1 Scope This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement…

Biological evaluation of medical devices - Sample preparation and reference materials

1 Scope This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device tes…

Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

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…