ASTM E2011-21

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.

General Information

• Status: Published
• Publication Date: 31-Mar-2021
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Standards Content (Sample)

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.
Designation: E2011 − 21
Standard Test Method for
Evaluation of Hygienic Handwash and Handrub
Formulations for Virus-Eliminating Activity Using the Entire
1
Hand
This standard is issued under the fixed designation E2011; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Mechanicalremovaland/orinsituinactivationofvirusesbyhygienichandwashandhandrubagents
can be assessed using artificially-contaminated hands of adults. This test method uses the entire
surface of both hands (including both the palmar and dorsum sides of the hands) in contrast to only
the fingerpads in the procedure described in Test Method E1838. However, the reported results from
2
these two methods are comparable. (1, 2)
1. Scope 2. Referenced Documents
3
2.1 ASTM Standards:
1.1 This test method is designed to evaluate handwash or
E1482Practice for Use of Gel Filtration Columns for Cyto-
handrub agents for their ability to reduce or eliminate viable
toxicity Reduction and Neutralization
viruses from the skin of human hands.
E1838Test Method for Determining the Virus-Eliminating
NOTE1—Aknowledgeofvirologicaltechniquesisrequiredforthistest
EffectivenessofHygienicHandwashandHandrubAgents
method.
Using the Fingerpads of Adults
1.2 The values stated in SI units are to be regarded as
E2756Terminology Relating toAntimicrobial andAntiviral
standard. No other units of measurement are included in this
Agents
standard.
2.2 AOAC Standard:
4
1.3 This standard may involve hazardous materials, opera-
AOAC 960.9 Official Methods of Analysis (2007)
tions and equipment. This standard does not purport to address
all of the safety concerns, if any, associated with its use. It is
3. Terminology
the responsibility of the user of this standard to establish
3.1 For definitions of terms used in this method refer to
appropriate safety, health, and environmental practices and
Terminology E2756.
determine the applicability of regulatory limitations prior to
3.2 Definitions of Terms Specific to This Standard:
use. The user should consult a reference for laboratory safety
3.2.1 hygienic handwash agents, n—agents generally used
recommendations. (3-5)
for handwashing by personnel in hospitals, other health-care
1.4 This international standard was developed in accor-
facilities, day-care centers, nursing homes, and food-handling
dance with internationally recognized principles on standard-
establishments; should be safe for repeated use, non-irritating,
ization established in the Decision on Principles for the
fast-acting, and efficient in eliminating transient microorgan-
Development of International Standards, Guides and Recom-
isms from intact skin.
mendations issued by the World Trade Organization Technical
3.2.2 hygienic handrub agents (that is, hand sanitizers),
Barriers to Trade (TBT) Committee.
n—agents not requiring rinsing and generally used for hand
hygiene by personnel in hospitals, other health-care facilities,
1
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
3
responsibility of Subcommittee E35.15 on Antimicrobial Agents. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved April 1, 2021. Published June 2021. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1999. Last previous edition approved in 2013 as E2011–13. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2011-21. the ASTM website.
2 4
The boldface numbers in parentheses refer to a list of references at the end of Available from AOAC International, 481 North Frederick Ave., Suite 500,
this test method. Gaithersburg, Maryland 20877-2417, http://www.aoac.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E2011 − 21
day-care centers, nursing homes, and food-handling establish- the host system at a dilution just beyond the cytotoxicity range
ments; should be safe for repeated use, non-irritating, fast- of the formulation tested. At least three replicate determina-
acting, and efficient in eliminating transient microorganisms tions are performed on controls (untreated) and test samples
from intact skin. (treated) to confirm the extent of virus elimination by the
number of lots of the te
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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.
Designation: E2011 − 13 E2011 − 21
Standard Test Method for
Evaluation of Hygienic Handwash and Handrub
Formulations for Virus-Eliminating Activity Using the Entire
1
Hand
This standard is issued under the fixed designation E2011; 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
Mechanical removal and/or in situ inactivation of viruses by hygienic handwash and handrub agents
can be assessed using artificially-contaminated hands of adults. This test method uses the entire
surface of both hands (including both the palmar and dorsum sides of the hands) in contrast to only
the fingerpads in the procedure described in Test Method E1838. However, the reported results from
2
these two methods are comparable. (1, 2)
1. 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
3
2.1 ASTM Standards:
E1482 Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the
Fingerpads of Adults
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides, Antimicrobials, and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2013April 1, 2021. Published May 2013June 2021. Originally approved in 1999. Last previous edition approved in 20092013 as
E2011 – 09.E2011 – 13. DOI: 10.1520/E2011-13.10.1520/E2011-21.
2
The boldface numbers in parentheses refer to a list of references at the end of this test method.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. 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 ----------------------
E2011 − 21
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
2.2 AOAC Standard:
4
AOAC 960.9 Official Methods of Analysis (2007)
3. Terminology
3.1 For definitions of terms used in this method refer to Terminology E2756.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 hygienic handwash agents, n—agents generally used for handwashing by personnel in hospitals, other health-care facilities,
day-care centers, nursing homes, and food-handling establishments; should be safe for repeated use, non-irritating, fast-acting, and
efficient in eliminating transient microorganisms from intact skin.
3.2.2 hygienic handrub agents (that is, hand sanitizers), n—agents not requiring rinsing and generally used for hand hygiene by
personnel in hospitals, other health-care facilities, day-care centers, nursing homes, and food-handling establishments; should be
safe for repeated use, non-irritating, fast-acting, and efficient in eliminating transient microorganisms from intact skin.
3.2.3 non-medicated soap, n—a soap or detergent that is mild to the skin and does not contain any germicidal chemicals.
3.2.4 soil (organic) load, n—a solution of one or more orga
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