ASTM D7427-08
Historical Standard: ASTM D7427-08 Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Natural Rubber and Its Products Derived from Latex
SUPERSEDED (see Active link, below)
ASTM D7427
1. Scope
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 natural rubber and its products derived from latex using monoclonal antibodies specific for epitopes on these proteins. Since these assays quantify the levels of only 4 of the known 13 officially acknowledged allergens potentially present in 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 natural rubber containing product.
1.3 The test method is not designed to evaluate the potential of 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 natural rubber containing products. It should not be used to describe, appraise or assess the hazard or risk of these 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
D1193 Specification for Reagent Water
D4483 Practice for Evaluating Precision for Test Method Standards in the Rubber and Carbon Black Manufacturing Industries
D4678 Practice for Rubber--Preparation, Testing, Acceptance, Documentation, and Use of Reference Materials
D5712 Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method
D6499 Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
Keywords
allergens; Hevea brasiliensis; IEMA; immunoenzymetric assay; natural rubber latex; proteins;
ICS Code
ICS Number Code 11.100.99 (Other standards related to laboratory medicine); 83.060 (Rubber)
DOI: 10.1520/D7427-08
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