Поиск

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. 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. Toxicokinetic study design for degradation products and leachables.

Biological evaluation of medical devices. Tests for systemic toxicity.

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

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. 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 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 18: Chemical characterization of materials

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

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 - 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 - 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 - 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…

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

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…

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1

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…

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

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…