ANSI/AAMI TIR52:2014(R2022)
最终灭菌保健品环境监测

Environmental monitoring for terminally sterilized healthcare products


 

 

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标准号
ANSI/AAMI TIR52:2014(R2022)
发布单位
美国国家标准学会
 
 
适用范围
This Technical Information Report (TIR) assists in establishing an environmental monitoring program that is meaningful, manageable and defendable, and provides guidance to avoid adverse environmental conditions during the manufacture of terminally sterilized healthcare products. The objective of this TIR is to provide guidance on the routine monitoring for viable and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.

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