ASTM D7427-08 PDF

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.