ISO 11137-2:2013/Amd 1:2022
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 2
- Дата публикации:
- 13 июня 2022 г.
- Издание:
- ISO IS 11137 edition 3 version 1
- ICS:
- 11.080.01
Abstract
Overview
ISO 11137-2:2013/Amd 1:2022 is an authoritative international standard focused on the sterilization of health care products using radiation. Specifically, it provides amendments to Part 2 of ISO 11137, which details the procedures for establishing the sterilization dose. This amendment updates guidelines on substantiating sterilization doses, ensuring enhanced accuracy, safety, and efficacy in sterilizing medical devices. Developed by ISO/TC 198 in cooperation with CEN/TC 204, this standard aligns with the Vienna Agreement, reflecting global best practices for radiation sterilization processes.
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