Standard No.:	YY/T 0618-2017
English Name:	Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing
Chinese Name:	医疗器械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
Issued by:	China Food and Drug Adminstration
Issued on:	2017-02-28
Implemented on:	2018-1-1
Status:	valid
Superseding:	YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing
Language:	English
File Format:	PDF
Word Count:	16500 words
Price(USD):	495.0
Delivery:	via email in 1~5 business day

本标准规定了测定医疗器械、组件或原材料的细菌内毒素试验方法的基本准则。
本标准适用于医疗器械细菌内毒素常规监控与跳批检验。