ISO 10993-4:2017/Amd 1:2025
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 7
- Дата публикации:
- 8 января 2025 г.
- Издание:
- ISO IS 10993 edition 3 version 1
- ICS:
- 11.100.20
Abstract
Overview
ISO 10993-4:2017/Amd 1:2025 is the latest amendment to the international standard for the biological evaluation of medical devices, specifically focusing on the selection of tests for interactions with blood. This amendment updates and clarifies protocols essential for assessing haemocompatibility-how medical devices interact safely and effectively with blood. Developed by ISO/TC 194 in collaboration with CEN/TC 206, the standard guides manufacturers and regulators in selecting appropriate testing methods to ensure device safety and performance in contact with blood.
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