EN ISO 10993-17:2023/A1:2025 PDF
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025)
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 14
- Дата публикации:
- 24 декабря 2025 г.
- Издание:
- CEN EN 10993 edition 1 version 1
- ICS:
- 11.100.20
Abstract
Overview
EN ISO 10993-17:2023/A1:2025 (Amendment 1 to ISO 10993-17:2023) updates guidance for the toxicological risk assessment of medical device constituents. This amendment clarifies exposure calculations, terminology and tables used to derive and worst‑case estimated exposure doses. It also aligns cross‑references to (chemical characterization) and clarifies the document’s relationship to Regulation (EU) 2017/745 (EU MDR).
Похожие стандарты
Стандарты, упомянутые в описании