Standard Number: YY/T 1649.1-2019(YY/T1649.1-2019)
Chinese: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
English:Test method for interactions of medical devices with platelet-Part 1:In vitro platelet count assay
Effective Date:2020-06-01
ICS:11.040.01
Standard Applicability:This standard specifies the platelet count test method for detecting the interaction of medical devices/materials with platelets in vitro in the evaluation of blood compatibility. This standard is applicable to the evaluation of platelet adhesion properties and activation potential on the surface of medical devices/materials. The test system established in this standard is applicable to human blood, and the use of animal blood for the test can refer to this standard, and its appropriateness should be demonstrated.
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