ISO 11135:2014/Amd 1:2018 PDF
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release
Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 15 октября 2018 г.
- Издание:
- ISO IS 11135 edition 2 version 1
- ICS:
- 11.080.01
Abstract
Overview
ISO 11135:2014/Amd 1:2018 is an important amendment to the international standard for the sterilization of health-care products using ethylene oxide. This standard outlines the . The 2018 amendment specifically revises Annex E, which addresses the procedure-a critical aspect for sterilizing small quantities such as during product research, development, or clinical trials.
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