ANSI/AAMI ST67-2003
医疗装置的消毒.贴有"已消毒"标签的产品要求

Sterilization of medical devices - Requirements for products labeled "STERILE"

ANSI/AAMI ST67-2003 发布历史

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.

ANSI/AAMI ST67-2003由US-AAMI 发布于 2003-12-18。

ANSI/AAMI ST67-2003 在中国标准分类中归属于: C04 基础标准与通用方法。

ANSI/AAMI ST67-2003的历代版本如下：

• 2003年12月18日 ANSI/AAMI ST67-2003 医疗装置的消毒.贴有"已消毒"标签的产品要求
• 2011年01月01日 ANSI/AAMI ST67-2011 保健品杀菌.选择标有"无菌"产品的灭菌保证水平(SAL)的要求和指导

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标准号

ANSI/AAMI ST67-2003

发布日期

2003年12月18日

实施日期

废止日期

无

中国标准分类号

C04

发布单位

US-AAMI

适用范围

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.

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