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

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

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

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

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 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 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 - 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 — 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…