ISO 10993-12:2021/Amd 1:2025
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 2
- Дата публикации:
- 13 августа 2025 г.
- Издание:
- ISO IS 10993 edition 5 version 1
- ICS:
- 11.100.20
Abstract
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 addresses sample preparation and reference materials necessary for assessing the biological safety of medical devices. This 2025 amendment refines and updates procedures and requirements to ensure greater accuracy and consistency during the sample processing stages in biological evaluations.
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