SIST EN ISO 10993-17:2024/A1:2026
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:
- 12 января 2026 г.
- Издание:
- ISO 10993-17:2023/Amd 1:2025
- ICS:
- 11.100.20
Abstract
Overview
SIST EN ISO 10993-17:2024/A1:2026 is the Slovenian adoption of Amendment 1 to the internationally recognized standard for medical device safety: ISO 10993-17, Part 17 - Toxicological risk assessment of medical device constituents. This standard, prepared by ISO Technical Committee 194 and CEN/TC 206, ensures consistent, harmonized approaches for assessing potential toxicological risks posed by materials and chemicals in medical devices. The amendment brings technical and editorial updates reflecting latest scientific knowledge and regulatory needs.
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