ASTM E2276-10
(Test Method)Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
SIGNIFICANCE AND USE
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.
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 ) are already ASTM standards.
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.
This test method is not meant for use with surgical hand scrubs (Test Method E1115) or preoperative skin preps (Test Method E1173).
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.
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 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.
General Information
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Designation: E2276 − 10
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adults
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.
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
E1173 Test Method for Evaluation of Preoperative,
1.2 Performance of this procedure requires the knowledge
3 Precatheterization, or Preinjection Skin Preparations
of regulations pertaining to the protection of human subjects.
E1174 Test Method for Evaluation of the Effectiveness of
1.3 The test method should be performed by persons with
Health Care Personnel Handwash Formulations
traininginmicrobiologyinfacilitiesdesignedandequippedfor
E1838 Test Method for Determining the Virus-Eliminating
work with infectious agents at biosafety level 2 (5).
Effectiveness of Hygienic Handwash and HandrubAgents
1.4 The values stated in SI units are to be regarded as Using the Fingerpads of Adults
E2613 Test Method for Determining Fungus-Eliminating
standard. No other units of measurement are included in this
standard. Effectiveness of Hygienic Handwash and HandrubAgents
Using Fingerpads of Adults
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions—Fordefinitionsofgeneraltermsusedinthis
priate safety and health practices and determine the applica-
test method, refer to Terminology D1129.
bility of regulatory limitations prior to use.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active ingredient, n—a substance added to a formula-
1
This test method is under the jurisdiction of ASTM Committee E35 on
tion specifically for the inhibition or inactivation of microor-
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
ganisms.
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2010. Published May 2010. Originally
ε1
approved in 2003. Last previous edition approved in 2003 as E2276 – 03 . DOI:
4
10.1520/E2276-10. 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 ----------------------
E2276 − 10
3.2.2 dry control, n—a control to determine the number of method gives results that are comparable to those obtained
colony forming units of the test bacterium remaining viable usingawhole-handprocedure (6).Iftwodifferentformulations
after the initial drying of the inoculum on the skin. are being compared in the same test, one of them may be
designated as a reference and used in place of the hard water
3.2.3 handrub, n—a liquid or gel which is applied by
...
This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
´1
Designation:E2276–03 Designation:E2276–10
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adult SubjectsAdults
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
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.
3
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
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
4
2.1 ASTM Standards:
D1129 Terminology Relating to Water
E1115
E1115 Test Method for Evaluation of Surgical Hand Scrub Formulations
E1173
E1173 Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
1
This test method is under the jurisdiction ofASTM Committee E35 on Pesticides andAlternative ControlAgents and is the direct responsibility of Subcommittee E35.15
on Antmicrobial Agents.
Current edition approved May 10, 2003. Published July 2003. DOI: 10.1520/E2276-03E01.on Antimicrobial Agents.
´1
Current edition approved April 1, 2010. Published May 2010. Originally approved in 2003. Last previous edition approved in 2003 as E2276 – 03 . DOI:
10.1520/E2276-10.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.
3
Federal Register, Vol 46, No. 17, Jan. 27, 1991.
4
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
---------------------- Page: 1 ----------------------
E2276–10
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents
UsingtheFingerpadsofAdultVolunteersTestMethodforDeterminingtheVirus-EliminatingEffectivenessofLiquidHygienic
Handwash and Handrub Agents Using the Fingerpads of Adults
E2613 Test Method for Determining Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using
Fingerpads of Adults
3. Terminology
3.1 Definitions—For definitions of general terms used in this test method, refer to Terminology D1129.
3.2
...
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