ASTM-D7427 2021

$44.96

D7427-16(2021) 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 Latex

Published By	Publication Date	Number of Pages
ASTM	2021	16

Guaranteed Safe Checkout

Categories: 11.100.99 - Other standards related to laboratory medicine, ASTM

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

ASTM D7427-16-Reapproved2021

Withdrawn Standard: Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex (Withdrawn 2023)

ASTM D7427

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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7 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

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/D7427-16R21

Additional information

Standard Title	D7427-16(2021) 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 Latex
Published Code	ASTM
Publication Date	2021
Pages Count	16
ICS Codes	11.100.99 - Other standards related to laboratory medicine