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ISO 11737-1-2018 医疗器械灭菌 微生物学方法 第1部分 产品上微生物群落的测定

发布时间:2022-10-28    浏览次数:3314

标准类别 国际标准发布日期

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标准状态 实施日期 ——
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ISO 11737-1-2018 医疗器械灭菌 微生物学方法 第1部分 产品上微生物群落的测定 介绍:

A sterile health care product is one that is free of viable microorganisms. International Standards that specify requirements for the validation and routine control of sterilization processes require, when it is necessary to supply a sterile health care product, that adventitious microbiological contamination of a health care product prior to sterilization be minimized. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.

ISO 11737-1-2018 医疗器械灭菌 微生物学方法 第1部分 产品上微生物群落的测定

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