标准编号:ISO/TS 11137-4:2020

中文名称:保健产品的灭菌 辐射 第4部分:过程控制指南

英文名称:Sterilization of health care products — Radiation — Part 4: Guidance on process control

发布日期:2020-06

标准范围

This document provides additional guidance to that given in ISO 11137-3 on meeting the requirements specified in ISO 11137-1, ISO 11137-2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and X-irradiation.

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