EN ISO 11137-2:2015/A1:2023 PDF
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 13
- Дата публикации:
- 19 апреля 2023 г.
- Издание:
- CEN EN 11137 edition 1 version 1
- ICS:
- 11.080.01
2022-06-21 - lack of compliance - publication on hold
Abstract
Overview
EN ISO 11137-2:2015/A1:2023 (ISO 11137-2:2013/Amd 1:2022) is a European amendment to the international standard on of health care products. It specifically addresses the process of for devices sterilized by ionising radiation. Prepared by ISO/TC 198 in collaboration with CEN/TC 204, the amendment updates clause content and normative references to support development, validation and routine control of radiation sterilization processes.
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