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Description of ASTM-E3131 2024ASTM E3131-17-Reapproved2024Active Standard: Standard Specification for Nucleic Acid-Based Systems for Bacterial Pathogen Screening of Suspicious Visible PowdersASTM E3131Scope 1.1 General: 1.1.1 This specification provides system designers, manufacturers, integrators, procurement personnel, end users/practitioners, and responsible authorities a common set of parameters to match the capabilities of biological assessment tools with user needs. 1.1.2 This specification is not meant to provide for all uses. Manufacturers, purchasers, and end users will need to determine specific requirements including, but not limited to, use by hazardous material (HAZMAT) teams and Urban Search and Rescue (US&R) teams, use in explosive or other hazardous environments or atmospheres, use with personal protective equipment (PPE), use by firefighters or law enforcement officers or both, special electromagnetic compatibility needs, extended storage periods, and extended mission time. These specific requirements may or may not be generally applicable to all nucleic acid-based detection systems. 1.2 Operational Concepts—Nucleic acid-based detection systems are used to detect, identify, or quantify, or combinations thereof, biological hazards to support short-term tactical decision making to protect responders and the public. The system should provide low false-positive and false-negative rates. Uses of these systems include survey, surveillance, and screening of samples, particularly during a response to a suspected biological agent incident. A field-deployable system should withstand the rigors associated with uses including, but not limited to, high- and low-temperatures and storage conditions, shock and vibration, radio frequency interference, and rapid changes in operating temperature and humidity. Note that this specification does not address testing the potential impact of the rigors associated with use of systems in the field. 1.3 Nucleic Acid-Based System Detection Capabilities—Manufacturers or independent third-party testing entities shall document and verify, through testing, the capabilities of the system. 1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. Liquid concentrations of the biohazard materials are presented in number of biological agents or genome equivalents per volume for pathogens such as bacteria and spores (biological agents/mL, genome equivalents/mL (GE/mL), colony forming units/mL (CFU/mL), or spores/mL). 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. Keywords biodetection assay; biological agent; biological assessment; biothreat agent; confidence interval; confidence level; deoxyribonucleic acid; DNA; field screening; first responder; homeland security; nucleic acid; pathogen; PCR; polymerase chain reaction; probability of detection; spore; suspicious powder; ICS Code ICS Number Code 13.300 (Protection against dangerous goods) DOI: 10.1520/E3131-17R24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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