ISO 10993-17:2023/Amd 1:2025
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 3
- Дата публикации:
- 18 ноября 2025 г.
- Издание:
- ISO IS 10993 edition 2 version 1
- ICS:
- 11.100.20
Abstract
Overview
ISO 10993-17:2023/Amd 1:2025 is the latest amendment to the international standard focused on the biological evaluation of medical devices, specifically addressing toxicological risk assessment of medical device constituents. This document, developed by ISO Technical Committee ISO/TC 194 in collaboration with CEN/TC 206, updates the guidance on assessing the toxicological risks posed by chemical constituents within medical devices. It ensures that manufacturers and regulatory bodies have clear, scientifically robust criteria to evaluate potential toxicological hazards associated with device materials.
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