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5.1 This test method is designed to evaluate the virus-eliminating activity of hygienic handwash and handrub agents from experimentally-contaminated hands. Such formulations may be further assessed in a clinical trial for their effectiveness in the field. This test method incorporates whole-hand exposure and reflects actual use conditions such as friction during hand decontamination, and enables alternative product forms such as alcohol- or non-alcohol-based liquids, gels, and foams to be tested according to label directions. It is meant to extend, if required, the results of testing with Test Method E1838, which gives precise reductions in viral infectivity on a limited area of the hands. It may also serve as an alternative test method when product form is not amenable to testing by Test Method E1838.5.2 This test method is not meant for use with surgical hand scrubs or preoperative skin preparations.NOTE 2: Application of viruses on the entire surface of both hands entails a greater risk to the subjects than using fingerpads only. Therefore, greater care is needed to ensure that the hands of the participants are free from any apparent damage. Also, virus preparations must be thoroughly screened for, or documented to be free from, extraneous or adventitious pathogens before use in such tests.1.1 This test method is designed to evaluate handwash or handrub agents for their ability to reduce or eliminate viable viruses from the skin of human hands.NOTE 1: A knowledge of virological techniques is required for this test method.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This standard may involve hazardous materials, operations and equipment. 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. (3-5)1.4 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 in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate selected types of bacteria from experimentally contaminated skin of the hands of adult subjects. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for viable bacteria remaining after the inoculum has been allowed to dry (two), bacteria eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the bacteria-eliminating efficiency of the product under test. No more than 100 µL of the test bacterial suspension is required to complete one test. The results of testing with this test method may form the basis for confirmatory tests using a suitable whole-hand test protocol, such as Test Method E1174.5.2 Whereas this test method relates to testing with bacteria, it can be readily adapted to work with protozoa and bacteriophages. Similar methods for work with fungi (Test Method E2613) and viruses of human origin (Test Method E1838) are already ASTM standards.5.3 Potentially infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (7). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid bacterial removal by the drying process itself.5.4 This test method is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).5.5 The level of contamination with viable bacteria on each fingerpad after the drying of the inoculum should be five- to ten-fold higher than the product performance criterion required. For example, the titer in the dried inoculum on each fingerpad should be about 105 colony forming units of the test bacterium when a >104 reduction is required under the conditions of this test method.1.1 This test method is designed to determine the activity of hygienic handwash and handrub (4) agents against transient bacterial flora on hands and is not meant for use with surgical hand scrubs or preoperative skin preps.1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.31.3 The test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 (5).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.

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5.1 This in vivo procedure is designed to test the ability of hygienic handwash or handrub agents to eliminate fungal contamination from experimentally-contaminated hands. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of an input control (two), control for culturable cells of the test fungus remaining after the inoculum has dried (two), fungal cells eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the fungus-eliminating efficiency of the formulation under test. No more than 100 µL of the test fungal suspension is required to complete one test.5.2 Whereas this practice is designed to work with fungi, similar ASTM standards exist for testing against viruses (Test Method E1838) and vegetative bacteria (Test Method E2276).5.3 The levels of culturable microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (5). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid fungal removal by the drying process itself.5.4 This practice is not designed to test surgical hand scrubs or preoperative skin preps.5.5 The level of contamination with culturable fungi on each fingerpad after the drying of the inoculum should be at least 104 CFU so that it would permit the detection of up to a 4-log10 reduction in the viability titer of the test organism by a test formulation under the conditions of this test. This in itself does not represent the product performance criterion, which may vary depending on the jurisdiction and the nature of the formulation being evaluated.1.1 This practice is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal contamination on hands (3) . This practice is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation.31.3 The practice should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at biosafety level 2 (4).1.4 Units—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.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.

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5.1 This in vivo procedure is designed to test the ability of hygienic handwash and handrub agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adults. Since the two thumbpads and all eight fingerpads can be contaminated with virus and used in a given test, it allows for the incorporation of a wet inoculum input control, dried virus recovery control, and up to three replicates to assess the virus-eliminating efficiency of a test or control agent, or a vehicle material. No more than 100 μL of the virus suspension are required to complete one test.5.2 This test method is designed to be performed by a trained individual, who is responsible for choosing the appropriate host system for the test virus and applying the techniques necessary for propagation and maintenance of host and test virus. For a reference text, refer to Lennette et al (12).5.3 Whereas the method described here relates to testing with viruses of human origin, it can be readily adapted to work with animal pathogenic viruses as well as bacteriophages. Standard methods for working with bacteria (Test Method E2276) and fungi (Test Method E2613) are also available.5.4 Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (13). A step for the drying of fingerpads after exposure to the control or test product, therefore, has not been included to avoid virus removal by the drying process itself.5.5 This test method is not meant for use with surgical hand scrubs or preoperative skin preps.5.6 The level of viable virus in the dried inocula the control fingerpads should not be less than 104 infectious units which would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by the test product under the conditions of this test method.1.1 Human skin is not known to carry viruses as a part of its resident microbiota, with the notable exception of papilloma viruses (10). Hands transiently contaminated with viruses can, however, act as vehicles for the spread of many types of viral infections. Hand hygiene is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reductions in the virus load may be due to a combination of virus inactivation and mechanical removal of infectious virus from the skin.1.2 This test method is designed to determine the comparative virus-eliminating effectiveness of microbicidal or non-microbicidal formulations. This test method is not meant for use with surgical hand scrubs or preoperative skin preps.NOTE 1: The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2 (11).1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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 and health practices and determine the applicability of regulatory limitations prior to use.1.5 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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This PDF includes GI #2. 1. Scope 1.1 These requirements apply to both cord-connected and permanently connected electric radiant heaters and infrared and ultraviolet lamp assemblies for warming food or for cosmetic or hygienic purposes in nonmedic

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