ASTM D7850 - 13 Standard Specification for Biological Properties of Industry Reference Materials (IRM)

ASTM D7850 - 13

Standard Specification for Biological Properties of Industry Reference Materials (IRM)

Active Standard ASTM D7850 | Developed by Subcommittee: D11.40

Book of Standards Volume: 09.02

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Abstract

This specification covers the biological quality specifications or requirements, or both, for Industry Reference Materials (IRMs) used to conduct product, specification, and development testing in the rubber and carbon black industries. A new lot of material can be accepted as an IRM only if complies with the requirements prescribed in this specification. However, there are other requirements given in Practice D4678 that shall be met before a candidate material can be formally accepted as a biological IRM. Biological IRMs covered by the specification include ammoniated latex antigenic protein, rabbit anti-AL antisera, and mouse monoclonal antibody.

This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.

1. Scope

1.1 This specification covers the biological quality specifications or requirements, or both, for Industry Reference Materials (IRMs) as cited in Practice D4678 and other standards.

1.2 IRMs, as evaluated and referenced in Practice D4678, are vitally important to conduct product, specification, and development testing in the rubber and carbon black industries.

1.3 Before a new lot of material can be accepted as an IRM, it must comply with the specifications prescribed in this specification. However, these specifications are only part of the requirements. Other requirements as given in Practice D4678 shall be met before a candidate material can be formally accepted as a biological IRM.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 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

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

D7427 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

ICS Code

ICS Number Code 83.020 (Manufacturing processes in the rubber and plastics industries); 83.060 (Rubber)

UNSPSC Code

UNSPSC Code 12171603(Carbon black); 13101501(Latex rubber)

Referencing This Standard

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DOI: 10.1520/D7850-13

Citation Format

ASTM D7850-13, Standard Specification for Biological Properties of Industry Reference Materials (IRM), ASTM International, West Conshohocken, PA, 2013, www.astm.org