技術(shù)資訊
ISO 11737-1-2018 醫療器械滅菌 微生物學(xué)方法 第1部分 產(chǎn)品上微生物群落的測定
發(fā)布時(shí)間：2022-10-28 瀏覽次數：3744
| 標準類(lèi)別 | 國際標準 | 發(fā)布日期 | —— |
|---|---|---|---|
| 標準狀態(tài) |  | 實(shí)施日期 | —— |
| 頒發(fā)部門(mén) | 廢止日期 | 暫無(wú) |
ISO 11737-1-2018 醫療器械滅菌 微生物學(xué)方法 第1部分 產(chǎn)品上微生物群落的測定 介紹：
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.
