ISO 11137-1:2006/Amd 2:2018
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4 and 11.2
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 1
- Дата публикации:
- 8 ноября 2018 г.
- Издание:
- ISO IS 11137 edition 1 version 1
- ICS:
- 11.080.01
Abstract
Overview
ISO 11137-1:2006/Amd 2:2018 is an important amendment to the international standard for the sterilization of healthcare products using radiation. This document focuses on . It specifically revises sections 4.3.4 and 11.2 of the original to improve clarity and provide additional guidance on dosimetry and operational procedures.
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