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

标准号：ANSI/AAMI ST 72-2002
中文标准名称：细菌内毒素.试验方法学、日常检测和交替性批量测试
英文标准名称：Bacterial endotoxins - Test methodologies,routine monitoring,and alternatives to batch testing
标准类型：C04
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C04
国际标准分类号：07.100.01
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.