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Description of ASTM-F2888 2019ASTM F2888-19Active Standard: Standard Practice for Platelet Leukocyte Count—An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular MaterialsASTM F2888Scope 1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382. 1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means. 1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions. Note 1: The results of this in-vitro test may not correspond to actual human response. 1.4 The values stated in SI (International System of Units) units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Some specific hazards statements are given in Section 8 on Hazards. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords hemocompatibility; leukocyte; platelet; thrombosis; ICS Code ICS Number Code 11.100.30 (Analysis of blood and urine) DOI: 10.1520/F2888-19 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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