ISO 10993-7:2008/Amd 1:2019
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 9 декабря 2019 г.
- Издание:
- ISO IS 10993 edition 2 version 1
- ICS:
- 11.100.20
Abstract
Overview
ISO 10993-7:2008/Amd 1:2019 is an important amendment to the international standard focused on the biological evaluation of medical devices, specifically addressing ethylene oxide (EO) sterilization residuals. Published by the International Organization for Standardization (ISO), this amendment clarifies the applicability of allowable residual limits of EO and its by-product, ethylene chlorohydrin (ECH), for vulnerable patient groups such as neonates and infants. It ensures that EO sterilization processes and residual limits consider the unique risks and exposure levels for these sensitive populations, enhancing patient safety and risk management in medical device sterilization.
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