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Description of ASTM-F2567 2010ASTM F2567-06-Reapproved2010Withdrawn Standard: Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)ASTM F2567Scope 1.1 This practice provides a protocol for rapid, in vitro functional screening for classical pathway complement activating properties of solid materials used in the fabrication of medical devices that will contact blood. 1.2 This practice is intended to evaluate the acute in vitro classical pathway complement activating properties of solid materials intended for use in contact with blood. For this practice, “serum” is synonymous with “complement.” 1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum [HS], using 0.1 mL serum per 13×100 mm disposable glass test tube. Procedure B describes assaying the exposed serum for significant functional classical pathway complement depletion (decrease in amount of C4) as compared to control serum samples not exposed to the material. The endpoint in Procedure B is lysis of sheep red blood cells (RBC) coated with antibody (hemolysin). 1.4 This practice does not address the use of plasma as a source of complement. 1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility. Practice F1984 provides guidance for testing solid materials for whole complement activation in human serum, but does not discriminate between the classical or alternative pathway of activation. Practice F2065 provides guidance for testing solid materials for alternative pathway complement activation in serum. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.7 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 and health practices and determine the applicability of regulatory limitations prior to use. Keywords biocompatibility; blood compatibility; classical pathway; complement testing; materials; medical devices; Blood materials/applications; Medical devices/equipment; Serum; Biocompatibility ICS Code ICS Number Code 11.100.20 (Biological evaluation of medical devices) DOI: 10.1520/F2567-06R10 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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