SIST EN ISO 10993-18:2020/A1:2023 PDF
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 (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 (ISO 10993-18:2020/Amd 1:2022)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 14 сентября 2023 г.
- ICS:
- 11.100.20
- Технический комитет:
- VAZ - Healthcare
Abstract
Overview
EN ISO 10993-18:2020/A1:2023 is the CEN-adopted amendment to ISO 10993-18 (Part 18 of the series) that updates guidance on , with a specific focus on the . The amendment clarifies editorial items, refines examples and tables, and provides additional detail on solvent/anti‑solvent guidance and quantification approaches used in extractables and leachables (E&L) profiling. This standard supports biological evaluation and is intended to be used alongside EU medical device requirements (Regulation (EU) 2017/745).
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