ANSI/AAMI ST67-2019
醫療裝置的消毒.貼有"已消毒"標簽的產品要求
Sterilization of medical devices - Requirements for products labeled "STERILE"
- 標準號
- ANSI/AAMI ST67-2019
- 發布
- 2019年
- 總頁數
- 41頁
- 發布單位
- US-AAMI
- 當前最新
- ANSI/AAMI ST67-2019
- 適用范圍
- This standard specifies requirements and provides guidance for selecting an appropriate SAI_ for a terminally sterilized medical device or a maximum contamination rate for an aseptically processed medical device that is labeled "STERILE." The requirements and guidance provided in this standard also apply to the selection of an appropriate SAL for a terminally sterilized medical device that is labeled "Sterile Fluid Path." This standard does not address medical devices that are not labeled =STERILE." For example, nonsterile medical devices that possess antimicrobial properties or contain preservatives for the control of microbial levels are not addressed. This standard also does not address products regulated as drugs or biologics by the FDA.