【国外标准】 Standard Specification for Biological Properties of Industry Reference Materials (IRM)

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.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 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.