EN ISO 10993-12:2021/A1:2025 PDF
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - Amendment 1 (ISO 10993 12:2021/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 12
- Дата публикации:
- 24 сентября 2025 г.
- Издание:
- CEN EN 10993 edition 1 version 1
- ICS:
- 11.100.20
Abstract
Overview
EN ISO 10993-12:2021/A1:2025 is an amendment to the established European Standard for the biological evaluation of medical devices, specifically focusing on sample preparation and reference materials. Published by the European Committee for Standardization (CEN), this amendment aligns with the requirements of Regulation (EU) 2017/745 for medical devices. The updated standard clarifies terminology, references, and procedures to ensure consistency and compliance within biological testing frameworks across Europe.
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