ASTM E2613-23

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  
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.  
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.

General Information

• Status: Published
• Publication Date: 31-Dec-2022
• 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: E2613 − 23
Standard Practice for
Determining the Fungus-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adults
This standard is issued under the fixed designation E2613; 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
Human hands are frequently in contact with other surfaces and can readily acquire transient
2
microbial contamination. Fungi are common among these types of contaminants (1, 2), particularly
in healthcare settings and where food is handled. Standardized methods to assess the fungus-
eliminating potential of handwash and handrub agents have not been available and this practice
addresses the gap.
1. Scope* mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This practice is designed to assess the ability of hygienic
handwash and handrub agents to reduce levels of fungal
2. Referenced Documents
contamination on hands (3). This practice is not meant for use
4
2.1 ASTM Standards:
with surgical hand scrubs (Test Method E1115) or preoperative
D1129 Terminology Relating to Water
skin preps (Test Method E1173).
E1054 Practices for Evaluation of Inactivators of Antimicro-
1.2 Performance of this procedure requires the knowledge
bial Agents
3
of regulations pertaining to human experimentation.
E1115 Test Method for Evaluation of Surgical Hand Scrub
1.3 The practice should be performed by persons with
Formulations
training in microbiology in facilities designed and equipped for
E1173 Practice for Evaluation of Preoperative,
work with infectious agents at biosafety level 2 (4).
Precatheterization, or Preinjection Skin Preparations
E1838 Test Method for Determining the Virus-Eliminating
1.4 Units—The values stated in SI units are to be regarded
Effectiveness of Hygienic Handwash and Handrub Agents
as standard. No other units of measurement are included in this
Using the Fingerpads of Adults
standard.
E2197 Quantitative Disk Carrier Test Method for Determin-
1.5 This standard does not purport to address all of the
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
safety concerns, if any, associated with its use. It is the
and Sporicidal Activities of Chemicals
responsibility of the user of this standard to establish appro-
E2276 Test Method for Determining the Bacteria-
priate safety, health, and environmental practices and deter-
Eliminating Effectiveness of Hygienic Handwash and
mine the applicability of regulatory limitations prior to use.
Handrub Agents Using the Fingerpads of Adults
1.6 This international standard was developed in accor-
E2756 Terminology Relating to Antimicrobial and Antiviral
dance with internationally recognized principles on standard-
Agents
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
3. Terminology
3.1 Definitions—For definitions of general terms used in this
1
This practice is under the jurisdiction of ASTM Committee E35 on Pesticides, practice, refer to Terminologies D1129 and E2756.
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
3.2 Definitions of Terms Specific to This Standard:
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Jan. 1, 2023. Published February 2023. Originally
approved in 2008. Last previous edition approved in 2014 as E2613 – 14. DOI:
4
10.1520/E2613-23. 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 [e-mail]. 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.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2613 − 23
3.2.1 active ingredient, n—a substance added to a formula- organisms remaining on the fingerpad are eluted and the
tion specifically for the inhibition or inactivation of microor- eluates assayed for fungal colony-forming units (CFU). Reduc-
ganisms. tions in the numbers of CFU after treatment with the control
and test agent(s) are then determined. If two different form
...

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: E2613 − 14 E2613 − 23
Standard Test Method Practice for
Determining the Fungus-Eliminating Effectiveness of
Hygienic Handwash and Handrub Agents Using the
1
Fingerpads of Adults
This standard is issued under the fixed designation E2613; 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
Human hands are frequently in contact with other surfaces and can readily acquire transient
2
microbial contamination. Fungi are common among these types of contaminants (1, 2), particularly
in healthcare settings and where food is handled. Standardized methods to assess the fungus-
eliminating potential of handwash and handrub agents have not been available and this test method
practice addresses the gap.
1. Scope Scope*
1.1 This test method practice is designed to assess the ability of hygienic handwash and handrub agents to reduce levels of fungal
contamination on hands (3). This test method practice is not meant for use with surgical hand scrubs (Test Method E1115) or
preoperative skin preps (Test Method E1173).
3
1.2 Performance of this procedure requires the knowledge of regulations pertaining to human experimentation.
1.3 The test method 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.
1
This test method practice 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, 2014Jan. 1, 2023. Published May 2014February 2023. Originally approved in 2008. Last previous edition approved in 20082014 as
E2613E2613 – 14.–08. DOI: 10.1520/E2613-14.10.1520/E2613-23.
2
The boldface numbers in parentheses refer to athe list of references at the end of this standard.
3
Federal Register, Vol 46, No. 17, Jan. 27, 1991.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2613 − 23
2. Referenced Documents
4
2.1 ASTM Standards:
D1129 Terminology Relating to Water
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E1115 Test Method for Evaluation of Surgical Hand Scrub Formulations
E1173 Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
E1838 Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the
Fingerpads of Adults
E2197 Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and
Sporicidal Activities of Chemicals
E2276 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using
the Fingerpads of Adults
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
3. Terminology
3.1 Definitions—For definitions of general terms used in this test method, practice, refer to Terminologies D1129 and E2756.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of microorganisms.
3.2.2 CFU, n—colony-forming units.
3.2.3 dry control—control, n—a control to determine the number of colony forming units (CFU) CFU of the test fungus remaining
viableculturable after the initial drying of the inoculum on the skin.
3.
...