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RISThrombogenicity Testing for Blood Contacting Medical Devices in an In Vitro Ovine Blood Loop1
Publisher: The American Society of Mechanical Engineers (ASME)
Development of a Novel Positive Control for the Standard Test Method for the Platelet Leukocyte Assay: An In Vitro Hemocompatibility Assessment of Blood Contacting Medical Devices1
Publisher: The American Society of Mechanical Engineers (ASME)
Improved Method for the ASTM Platelet and Leukocyte Assay: Use of Minimal Heparinization in a Screening Test for Hemocompatibility of Blood-Contacting Medical Devices
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Most blood-contacting medical devices must be assessed for potential thrombogenicity prior to regulatory approval. A common assay for screening and qualifying devices involves monitoring the reduction of platelet and ...
Thrombogenicity Testing of Medical Devices in a Minimally Heparinized Ovine Blood Loop
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: ISO 10993-4 in vivo thrombogenicity testing is frequently performed for regulatory approval of many blood-contacting medical devices and is often a key part of submission packages. Given the current state of in vivo ...