ANSI/AAMI ST 72-2002
细菌内毒素.试验方法学、日常检测和交替性批量测试

Bacterial endotoxins - Test methodologies,routine monitoring,and alternatives to batch testing

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标准号

ANSI/AAMI ST 72-2002

发布

2002年

发布单位

美国国家标准学会

 

 

引用标准

ISO 9001:2000

适用范围

Specifies general criteria to be applied in the determination of bacterial endotoxins (pyrogens) on sterilized or sterilizable healthcare products, components or raw materials. Endotoxin methodologies covered include both qualitative (limit) methods and quantitative (end-point) methods. Determination of pyrogens other than bacterial endotoxins is not covered and acceptable levels for bacterial endotoxins are not covered.This standard was listed for public review in the 4/20/2001 issue of Standards Action. It is being resubmitted due to substantive changes to the text.

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