Standard Number: YY/T 1649.2-2019(YY/T1649.2-2019)
Chinese: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
English:Test method for interactions of medical devices with platelet -Part 2: In vitro platelet activation products (β-TG, PF4 and TxB2) assay
Effective Date:2020-10-01
ICS:11.040.01
Standard Applicability:This standard specifies the in vitro platelet activation test method for the interaction of medical devices/materials with platelets when the medical devices/materials are evaluated for blood compatibility in vitro. 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. If animal blood is used, the test may be conducted on the basis of demonstrating its suitability.
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