Standard No.:	YY/T 1649.1-2019
English Name:	Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay
Chinese Name:	医疗器械与血小板相互作用试验 第1部分：体外血小板计数法
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:	National Medical Products Adminstration
Issued on:	2019-05-31
Implemented on:	2020-6-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	3500 words
Price(USD):	105.00
Delivery:	via email in 1~3 business day

本标准规定了用于在血液相容性评价中检测医疗器械/材料在体外与血小板相互作用的血小板计数试验方法，本标准适用于医疗器械/材料表面血小板粘附性能和激活潜能的评价。本标准中建立的试验体系适用于人血，使用动物血液进行试验，可参照本标准，其适宜性应进行论证。