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ASTM E1482-12(2017)

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ASTM E1482-12(2017) Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization

standard by ASTM International, 11/01/2017

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Note 1:The title was formerly Standard Test Method for Neutralization of Virucidal Agents in Virucidal Efficacy Evaluations.

1.1This practice is intended to be used to reduce the cytotoxic level of the virus-test product mixture prior to assaying for viral infectivity. It is used in conjunction with evaluations of the virucidal efficacy of disinfectant solutions, wipes, trigger sprays, or pressurized disinfectant spray products intended for use on inanimate, nonporous environmental surfaces. This practice may also be used in the evaluation of hygienic handwashes/handrubs, or for other special applications. The practice may be employed with all viruses and host systems.

1.2This practice should be performed only by persons trained in virology techniques.

1.3This practice utilizes gel filtration technology. The effectiveness of the practice is dependent on the ratio of gel bed volume to sample size and uniformity in the preparation of columns as well as the conditions of entrifugation. The effectiveness of this practice is maximized by investigator practice and experience with gel filtration techniques.

1.4This practice will aid in the reduction, but not necessarily elimination, of test product toxicity while preserving the titer of the input virus.

1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6This 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.

1.7This 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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Published: 11/01/2017 Number of Pages: 3File Size: 1 file , 68 KB