Standard No.:	YY/T 1649.2-2019
English Name:	Test method for interactions of medical devices with platelet — Part2 : In vitro platelet activation products ( β -TG, PF4 and TxB2 ) assay
Chinese Name:	医疗器械与血小板相互作用试验 第2部分：体外血小板激活产物（β-TG、PF4和TxB2）的测定
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:	2019-10-23
Implemented on:	2020-10-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	6000 words
Price(USD):	140.00
Delivery:	via email in 1~5 business day

本标准规定了在体外对医疗器械/材料进行血液相容性评价时，医疗器械/材料与血小板相互作用的体外血小板激活试验方法。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。若使用动物血液，可在论证其适宜性的基础上进行试验。