Standard No.:	YY/T 1295-2015
English Name:	Biological evaluation of medical devices―Nanomaterial:Endotoxin test
Chinese Name:	医疗器械生物学评价 纳米材料：细菌内毒素试验
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2016-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	310.0
Delivery:	via email in 1~5 business day

本标准规定了应用鲎试验评价的纳米材料，用于细胞的体外生物学试验系统的术语、定义和试验方法等要求。
本标准适用于能够被水性介质（例如：水、血清或反应介质）分散或浸提的纳米材料，包括组合在医疗器械中的纳米材料。