Standard No.:	YY/T 0618-2007
English Name:	Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing
Chinese Name:	细菌内毒素试验方法常规监控与跳批检验
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	China Food and Drug Administration
Issued on:	2007-07-02
Implemented on:	2008-3-1
Status:	superseded
Superseded by:	YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing
Superseded on:	2018-1-1
Target Language:	English
File Format:	PDF
Word Count:	11500 words
Translation Price(USD):	345.0
Delivery:	via email in 1~5 business day

本标准规定了适用于测定医疗器械、组件或原材料的细菌内毒素试验方法的基本准则。
本标准给出的细菌内毒素试验方法包括定性和定量两种方法。
本标准不适用于测定细菌内毒素之外的热原。