SIST EN ISO 10993-4:2017/A1:2025 PDF
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 16
- Дата публикации:
- 10 марта 2025 г.
- Издание:
- ISO 10993-4:2017/Amd 1:2025
- ICS:
- 11.100.20
Abstract
Overview
EN ISO 10993-4:2017/A1:2025 is the CEN-endorsed amendment to ISO 10993‑4 (Part 4 of the ISO 10993 series) that updates guidance for the biological evaluation of medical devices with respect to . Published February/April 2025 and approved by CEN, this amendment clarifies device categories, refines test selection for , and aligns testing practice with risk management and EU regulatory expectations (see Annex ZA relating to Regulation (EU) 2017/745).
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