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ASTM E2276-03e1

(Test Method)

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects

SCOPE
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.
1.3 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 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.

General Information

Status
Historical
Publication Date
09-May-2003
ICS
71.100.70 - Cosmetics. Toiletries
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaces
ASTM E2276-03 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects
Effective Date
10-May-2003
Replaced By
ASTM E2276-10 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Effective Date
01-Apr-2010
Referred By
ASTM E1838-17 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Effective Date
10-May-2003
Referred By
ASTM E1327-07(2018) - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
Effective Date
10-May-2003
Referred By
ASTM E2613-23 - Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Effective Date
10-May-2003
Referred By
ASTM E2755-22 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
Effective Date
10-May-2003

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ASTM E2276-03e1 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult SubjectsASTM E2276-03e1 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects
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ASTM E2276-03e1 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Subjects
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information.
´1
Designation:E2276–03
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adult Subjects
This standard is issued under the fixed designation E2276; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
´ NOTE—Editorial corrections were made throughout in July 2004.
INTRODUCTION
2
Hands can spread many types of pathogens directly (1) or by transfer of such organisms to other
surfaces and objects during casual contact (2,3). Therefore, regular and proper decontamination of
hands by caregivers and food-handlers in particular is crucial for infection control. Hygienic hand
antisepsis is meant to reduce the load of transient microflora on hands, thereby reducing the risk of
disease transmission. Such reduction in the bacterial load may be due to a combination of bacterial
inactivation and removal of viable bacteria from the skin. In this method the test bacterial suspension
is placed on the thumb- and fingerpads of adults to simulate the contamination of hands with transient
microflora, the inoculum on the fingerpads is allowed to dry and is then treated with test and control
solutions. Since in each test all ten digits on any given subject can be used, the protocol permits the
inclusion of the required controls and several replicates of the test formulation in the same trial.
1. Scope 2. Referenced Documents
4
1.1 This test method is designed to determine the activity of 2.1 ASTM Standards:
hygienic handwash and handrub (4) agents against transient D1129 Terminology Relating to Water
bacterial flora on hands and is not meant for use with surgical E1115 Test Method for Evaluation of Surgical Hand Scrub
hand scrubs or preoperative skin preps. Formulations
1.2 Performance of this procedure requires the knowledge E1173 TestMethodforEvaluationofPreoperative,Precath-
3
of regulations pertaining to the protection of human subjects. eterization, or Preinjection Skin Preparations
1.3 The test method should be performed by persons with E1174 Test Method for Evaluation of the Effectiveness of
traininginmicrobiologyinfacilitiesdesignedandequippedfor Health Care Personnel Handwash Formulations
work with infectious agents at biosafety level 2 (5). E1838 Test Method for Determining the Virus-Eliminating
1.4 This standard does not purport to address all of the Effectiveness of Liquid Hygienic Handwash and Handrub
safety concerns, if any, associated with its use. It is the Agents Using the Fingerpads of Adult Volunteers
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety and health practices and determine the applica-
3.1 Definitions—For definitions of general terms used in
bility of regulatory limitations prior to use.
this test method, refer to Terminology D1129.
3.2 Definitions of Terms Specific to This Standard:
1
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides and is the direct responsibility of Subcommittee E35.15 onAntmicrobial
Agents.
Current edition approved May 10, 2003. Published July 2003. DOI: 10.1520/
4
E2276-03E01. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
2
The boldface numbers in parentheses refer to the list of references at the end of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
this standard. Standards volume information, refer to the standard’s Document Summary page on
3
Federal Register, Vol 46, No. 17, Jan. 27, 1991. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
E2276–03
3.2.1 active ingredient, n—a substance added to a formula- control and test agents are then determined. The fingerpad
tion specifically for the inhibition or inactivation of microor- method gives results that are comparable to those obtained
ganisms. usingawhole-handprocedure(6).Iftwodifferentformulations
3.2.2 dry control, n—a control to determine the number of are being compared in the same test, one of them may be
colony forming units of the test bacterium remaining viable designated as a reference and used in place of the hard water
after the initial drying of the inoculum on the skin. control. If desired, one also may use tap water in parallel with
3.2.3 handrub, n—a liquid or gel which is applied by the hard water control to determine the influence of water
rubbing to decontaminate lightly soiled hands between hand- hardness on the test product’s bacteria-eliminating ac
...

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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.
SCOPE
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.3  
1.3 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.  
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ASTM E2011-21(Test Method)
Standard Test Method for Evaluation of Hygienic Handwash and Handrub Formulations for Virus-Eliminating Activity Using the Entire Hand

SIGNIFICANCE AND USE
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.
SCOPE
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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ASTM E2870-19(Practice)
Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling

SIGNIFICANCE AND USE
5.1 Hand hygiene is important for preventing the spread of many types of infections.  
5.2 During routine activities, it is primarily the palmar surface, comprising palms, fingers, and finger pads, of the hands that may become contaminated with transient microorganisms. The contamination could then be transferred to articles touched or handled or to other parts of the body. Palmar contamination is used in Test Method E2784.  
5.3 In Test Method E1174, incomplete drying of the experimentally contaminated hands dilutes the applied test product, thus compromising its activity. Application of a smaller volume of the microbial test suspension keeps the soil load to a reasonable level while allowing the hands to become visibly dry prior to application of the test material and reference formulation. These modifications are aimed at producing a better approximation of in-use conditions and a more realistic assessment of the test substance, thus providing a more reliable indication of product performance.  
5.4 Unlike Test Methods E1174, E2755, and E2784, this practice enables a direct comparison between two formulations on the same subject. The practice also uses a mechanical scrubbing machine in conjunction with the glove juice technique for more efficient recovery of viable test bacteria from the palms. The mechanical sampling results in greater recovery of bacteria from the palms than conventional recovery methods, such as massaging.
SCOPE
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Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
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.  
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4.1 The procedure should be used to test the degerming effectiveness of antimicrobial hand washing products used by health care personnel that are intended for frequent use, and that are intended to reduce the level of contamination acquired through contact with contaminated objects or people.  
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SCOPE
1.1 This test method can be used to determine the effectiveness of antimicrobial handwashing agents (including handrubs) in the reduction of transient bacterial flora with particular emphasis on the fingernail region.  
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ASTM E1838-17(Test Method)
Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
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.  
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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.
SCOPE
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.  
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Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination

SIGNIFICANCE AND USE
5.1 This procedure has been designed to evaluate handwash products using a palmar surface only contamination method. This method is an alternative contamination procedure to that listed in Test Method E1174. The current contamination procedure in Test Method E1174 describes a standardized procedure for contaminating the entire hand, palmar surface and back, directly using a marker organism. The contamination procedure in Test Method E1174 does not necessarily represent real world hand contamination. During routine activities it is only the palmar surface, comprising palms, fingers, and finger pads of the hands that becomes contaminated by contact with transient microorganisms. These microorganisms can then be transferred to food or objects. Methods to measure the amount of microorganisms transferred to food or objects can be found in Fischler et al5 and Fuls et al6 and will be developed into a future ASTM standard.
SCOPE
1.1 This test method covers the determination of the effectiveness of antimicrobial handwashing agents for the reduction of transient microbial flora when used in a handwashing procedure.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 This test method may be used to evaluate topical antimicrobial handwash formulations.  
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.2  
1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and SI units follow in parentheses.  
1.6 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. For more specific precautionary statements see 8.5.

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ASTM E2613-23(Practice)
Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

SIGNIFICANCE AND USE
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.
SCOPE
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.3  
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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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ASTM E3288-22(Guide)
Standard Guide for Screening and Training of Assessors and a General Approach for the Sensory Evaluation of Oral Care Products: Toothpaste and Toothbrushes

SIGNIFICANCE AND USE
5.1 The approaches to the evaluation of toothbrushes and toothpaste recommended in this guide can be used to assess the sensory characteristics of toothpaste in use and after use (or a series of uses). This guide is meant to address the evaluation of standalone toothbrush and toothpaste products and does not address packaging, product/package interaction, dispensing, or overall clinical effect or benefit of the product. The procedures outlined in this guide are to be used by assessors that have been specifically screened for sensory and descriptive ability and trained in the evaluation of toothbrushes or toothpaste or both. The procedures described in this guide can be used to guide product development within a manufacturer and communicate information regarding the product to the consumer through the media or on product packaging.  
5.2 Additionally, language and ideas from two additional ASTM International sensory guides (Guides E1490 and E2082) as well as the Lexicon for Sensory Evaluation: Aroma, Flavor, Texture, and Appearance (DS72-2ND)4 are used throughout this guide.
SCOPE
1.1 This guide provides guidelines for the selection and training of expert assessors for the sensory evaluation of toothpaste and toothbrushes as well as a basic framework for the sensory evaluation of the same. Sensory evaluation of toothpaste and toothbrushes can be used to define the sensory attributes of the products and then to measure those attributes quantitatively for the purposes of new product development, product optimization, competitive benchmarking, and claims substantiation.  
1.2 A general framework for both toothpaste and toothbrush descriptive analysis is provided to guide the reader in the design and execution (including sample preparation and presentation, facility and testing environment, and specific evaluation protocols) for such evaluations.  
1.3 This guide provides suggested protocols and approaches to the evaluation of the indicated products/samples and in no way excludes any alternate approaches that may be effective in providing such perceptual evaluations.  
1.4 This guide does not address other oral care products including, but not limited to, whitening agents, oral rinses, mouthwashes, dental flosses, denture adhesive, floss picks, or other oral care products.  
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.

  • Guide
    8 pages
    English language
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