4.1 Contaminated sites subject to remediation are growing in complexity and associated remediation costs, presenting a challenge for managers of contaminated sites. The need to properly monitor, evaluate, and report remediation processes (including physical, chemical, and biological) characterizing site conditions and contaminant mass and attenuation is critical for the evaluation and selection of effective remediation strategies. Assessment and characterization of biological processes associated with contaminant attenuation is supported and improved by the accurate and consistent use of molecular biological tools (MBTs) including data acquisition, interpretation, and reporting.4.2 The development of this guide through ASTM International is designed to meet the needs of managers of contaminated sites within the United States and elsewhere. The variety of available MBTs and the complexity with which they are currently being applied are not addressed in existing ASTM International Standards. The principal users of this guide should be industry project managers, regulators, consultants, analytical laboratories, and community stakeholders.1.1 This guide provides a framework for the application of molecular biological tools (MBTs) to assess and characterize in-situ biological processes to improve contaminated soil and groundwater management. While the focus of this guide is on in-situ biological processes, some concepts of how to apply MBTs can also be applied to ex-situ bioremediation approaches (for example, biopiles, bioreactors) to support design, operation, and troubleshooting. The intent of this guide is to develop a consistent way in which MBTs are applied at contaminated sites, not to develop expertise. Technical experts need to be engaged whenscoping, planning, executing, and interpreting data for MBTs. Lastly, there is a brief description of isotopic techniques within section 5.2; however, the scope and focus of this guide is the use of nucleic acid-based MBTs to assess biological processes at contaminated sites.1.2 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.1.3 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.

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5.1 This practice is to determine if a test substance can inactivate viruses in suspension.5.2 Regulatory agencies may require additional testing using in vitro (Practice E1053, Test Method E2197) or in vivo (Test Method E1838) carrier tests for product registration purposes.1.1 This practice is intended to demonstrate the virucidal activity of test substances with viruses in suspension.1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practice regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions).1.3 Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.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. The user should consult a reference for the laboratory safety recommendations.21.6 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.

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5.1 This practice may be used to determine the effectiveness of liquid, aerosols/foams, and trigger-spray products against designated prototype viruses.5.2 The number of lots of the test substance and the number of replicates in each test will depend on the requirements of the target regulatory agency.5.3 Certain regulatory agencies may require additional testing using other carrier tests for product registration purposes.1.1 This practice is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, nonporous environmental surfaces. This practice may be employed with most viruses, which can be grown in cultured cells.2 However, other host systems (for example, embryonic eggs) may be used with proper justification and documentation.1.2 This practice should be performed only by those trained in microbiological and virological techniques in facilities designed and equipped for work with infectious agents at the appropriate biosafety level.1.3 It is the responsibility of the investigator to determine whether Good Laboratory Practice regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.1.4 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. The user should consult a reference for laboratory safety recommendations.21.5 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.

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