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Description of ASTM-D7427 2016ASTM D7427-16Historical Standard: Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from LatexASTM D7427Scope 1.1 This test method covers an immunological method known as an immunoenzymetric assay to quantify the amount of 4 principal Hevea brasiliensis [Hev b] allergenic proteins [Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02] in Hevea natural rubber and its products2 derived from latex using monoclonal antibodies specific for epitopes on these proteins. Since these assays quantify the levels of only 4 of the known 14 officially acknowledged allergens potentially present in Hevea natural rubber latex containing products, the sum of the four allergen levels shall be viewed as an indicator of the allergen burden and not as a measure of the total allergen content that can be released from the product. 1.2 For the purpose of this test method, the range of allergenic protein will be measured in terms of nanogram to microgram quantities per gram or unit surface area of a Hevea natural rubber containing product. 1.3 The test method is not designed to evaluate the potential of Hevea natural rubber containing materials to induce or elicit Type I (IgE-mediated) hypersensitivity reactions. 1.4 This test method should be used under controlled laboratory conditions to detect and quantify the level of 4 allergenic proteins found in Hevea natural rubber containing products. It should not be used to describe, appraise or assess the hazard or risk of these Hevea natural rubber containing materials or products under actual in use conditions. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 allergens; Hevea brasiliensis; IEMA; immunoenzymetric assay; Hevea natural rubber latex; proteins; ICS Code ICS Number Code 11.100.99 (Other standards related to laboratory medicine) DOI: 10.1520/D7427-16 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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