ISO 10993-18:2020/Amd 1:2022
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 11 мая 2022 г.
- Издание:
- ISO IS 10993 edition 2 version 1
- ICS:
- 11.100.20
Abstract
Overview
ISO 10993-18:2020/Amd 1:2022 is an important amendment to the international standard for the biological evaluation of medical devices, specifically addressing the chemical characterization of medical device materials within a risk management process. This amendment focuses on the , a key element in analytical quantification related to extractables and leachables from medical device materials. By refining how uncertainty factors are calculated and applied, the document enhances the precision and reliability of chemical evaluations tied to toxicological risk assessments.
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