ISO 11137-1:2006/Amd 1:2013 PDF
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 1
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 16 июля 2013 г.
- Издание:
- ISO IS 11137 edition 1 version 1
- ICS:
- 11.080.01
Abstract
Overview
ISO 11137-1:2006/Amd 1:2013 is an important amendment to the international standard that specifies the requirements for the development, validation, and routine control of radiation sterilization processes for medical devices. Published by the International Organization for Standardization (ISO), this amendment refines the procedures and definitions to ensure consistent sterility assurance when using radiation methods. The standard applies to health care products sterilized by radiation such as gamma rays, X-rays, or electron beams.
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