ASTM E1174-21

Standard Test Method for Evaluation of the Effectiveness of Healthcare Personnel Handwash Formulations

SIGNIFICANCE AND USE
5.1 The procedure is used to test the antimicrobial effectiveness of handwashing formulations. The test formulations generally are designed for frequent use to reduce the transient bacterial flora on hands. Alcohol-based hand rubs and other leave-on formulations used without the aid of water should be tested using Test Method E2755.
SCOPE
1.1 This test method is designed to determine the effectiveness of antimicrobial handwashing agents for the reduction of transient microbial skin flora when used in a handwashing procedure.2  
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.3  
1.5 The values stated in SI units are to be regarded as standard; except for distance, in which case inches are used and metric 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.For more specific precautionary statements see 8.2.  
1.7 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: 30-Sep-2021
• ICS: 71.100.40 - Surface active agents
• 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: E1174 − 21
Standard Test Method for
Evaluation of the Effectiveness of Healthcare Personnel
1
Handwash Formulations
This standard is issued under the fixed designation E1174; 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.
1. Scope 2. Referenced Documents
4
1.1 This test method is designed to determine the effective-
2.1 ASTM Standards:
ness of antimicrobial handwashing agents for the reduction of E1054PracticesforEvaluationofInactivatorsofAntimicro-
transient microbial skin flora when used in a handwashing
bial Agents
2
procedure. E2755 Test Method for Determining the Bacteria-
Eliminating Effectiveness of Healthcare Personnel Hand
1.2 A knowledge of microbiological techniques is required
Rub Formulations Using Hands of Adults
for these procedures.
E2756Terminology Relating toAntimicrobial andAntiviral
1.3 This test method may be used to evaluate topical
Agents
antimicrobial handwash formulations.
3. Terminology
1.4 Performance of this procedure requires the knowledge
3
of regulations pertaining to the protection of human subjects.
3.1 Definitions—For definitions of terms used in this
method, refer to Terminology E2756.
1.5 The values stated in SI units are to be regarded as
standard;exceptfordistance,inwhichcaseinchesareusedand
3.2 Definitions of Terms Specific to This Standard:
metric units follow in parentheses.
3.2.1 active ingredient, n—a substance added to a formula-
tion specifically for the inhibition or inactivation of microor-
1.6 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the ganisms.
responsibility of the user of this standard to establish appro-
3.2.2 healthcare personnel handwash, n—a cleanser or
priate safety, health, and environmental practices and deter-
waterlessagentintendedtoreducetransientmicroorganismson
mine the applicability of regulatory limitations prior to use.For
the hands.
more specific precautionary statements see 8.2.
3.2.3 resident microorganisms, n—microorganisms that live
1.7 This international standard was developed in accor-
and multiply on the skin, forming a permanent population.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 3.2.4 test formulation, n—a formulation which incorporates
Development of International Standards, Guides and Recom- antimicrobial ingredient(s).
mendations issued by the World Trade Organization Technical
3.2.5 test organism, n—an applied inoculum of bacterial
Barriers to Trade (TBT) Committee.
culture that has characteristics which allow it to be readily
identified.
3.2.5.1 Discussion—The test organism is used to simulate a
1
This test method is under the jurisdiction of ASTM Committee E35 on
transienttopicalmicrobialcontaminant.Itmayalsobereferred
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
to as a marker organism, bacterial simulant, or bacterial
responsibility of Subcommittee E35.15Antimicrobial Agents.
contaminant.
Current edition approved Oct. 1, 2021. Published October 2021. Originally
approved in 1987. Last previous edition approved in 2013 as E1174–13. DOI:
10.1520/E1174-21.
2
ThisversionofthestandardhasbeenrevisedtoalignwithcurrentUnitedStates
4
Food and Drug Administration requirements for healthcare personnel handwash For referenced ASTM standards, visit the ASTM website, www.astm.org, or
formulations. The procedure for multiple washes present in earlier versions of this contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
standard has been moved to Appendix X1 of this version. Standards volume information, refer to the standard’s Document Summary page on
3
45CFR Part 46 Protection of Human Subjects (Effective July 19, 2018) the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E1174 − 21
from most local laboratory supply houses.
3.2.6 transient microorganisms, n—organisms from the en-
vironment that contaminate but do not normally colonize the
7.2 Water Dilution Bottles—Any sterilizable glass container
skin.
having a 150mLto 200 mLcapacity and tight closures can be
used.
4. Summary of Test Method
NOTE 2—Milk dilution bottles of 160mL capacity having a screw-cap
4.1 This test method is conducted on a group of volunteer
closure are available f
...

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: E1174 − 13 E1174 − 21
Standard Test Method for
Evaluation of the Effectiveness of Health Care Healthcare
1
Personnel Handwash Formulations
This standard is issued under the fixed designation E1174; 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. Scope
1.1 This test method is designed to determine the effectiveness of antimicrobial handwashing agents for the reduction of transient
2
microbial skin 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.
3
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.
1.5 The values stated in SI units are to be regarded as standard; except for distance, in which case inches are used and metric 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.For more specific precautionary statements see 8.2.
1.7 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
4
2.1 ASTM Standards:
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E2755 Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations
Using Hands of Adults
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
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 E35.15Antimicrobial Agents.
Current edition approved Feb. 15, 2013Oct. 1, 2021. Published February 2013October 2021. Originally approved in 1987. Last previous edition approved in 20062013
as E1174 – 06.E1174 – 13. DOI: 10.1520/E1174-13.10.1520/E1174-21.
2
Federal Register,This version Vol 46, No. 17,of the standard has Jan. 27, 1991.been revised to align with current United States Food and Drug Administration
requirements for healthcare personnel handwash formulations. The procedure for multiple washes present in earlier versions of this standard has been moved to Appendix
X1 of this version.
3
45CFR Part 46 Protection of Human Subjects (Effective July 19, 2018)
4
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 ----------------------
E1174 − 21
3. Terminology
3.1 Definitions—For definitions of terms used in this method, refer to Terminology E2756.
3.2 Definitions: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.
3.1.2 cleansing wash, n—a non-antimicrobial wash intended to remove gross soil or residues from the hands of the panelists prior
to the conduct of the study and as noted throughout the study. This may also be referred to as a cosmetic wash.
3.2.2 healthcare personnel handwash, n—a cleanser or waterless agent intended to reduce transient bacteriamicroorganisms on the
hands.
3.1.4 neutralization, n—a process which results in quenching the antimicrobial activity of a test material. This may be achieved
through dilution of the test material(s) to reduce the antimicrobial activity, or through the use of chemical agents, called
neutralizers, to eliminate antibacterial activity.
3.2.3 resident microorganisms, n—microorganisms that live and multiply on the skin, forming a permanent population.
3.2.4 test fo
...