ASTM E1174-13

Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations

SIGNIFICANCE AND USE
5.1 The procedure may be used to test the effectiveness of antimicrobial handwashing agents. The test formulations may be 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 may 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 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 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 and health practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements see 8.2.

General Information

• Status: Historical
• Publication Date: 14-Feb-2013
• 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)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation: E1174 − 13
Standard Test Method for
Evaluation of the Effectiveness of Health Care 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 3.1.1 active ingredient, n—a substance added to a formula-
tion specifically for the inhibition or inactivation of microor-
1.1 This test method is designed to determine the effective-
ganisms.
ness of antimicrobial handwashing agents for the reduction of
3.1.2 cleansingwash,n—anon-antimicrobialwashintended
transient microbial flora when used in a handwashing proce-
toremovegrosssoilorresiduesfromthehandsofthepanelists
dure.
prior to the conduct of the study and as noted throughout the
1.2 A knowledge of microbiological techniques is required
study. This may also be referred to as a cosmetic wash.
for these procedures.
3.1.3 healthcare personnel handwash, n—a cleanser or
1.3 This test method may be used to evaluate topical
waterless agent intended to reduce transient bacteria on the
antimicrobial handwash formulations.
hands.
1.4 Performance of this procedure requires the knowledge
3.1.4 neutralization, n—a process which results in quench-
2
of regulations pertaining to the protection of human subjects.
ing the antimicrobial activity of a test material. This may be
1.5 The values stated in SI units are to be regarded as
achieved through dilution of the test material(s) to reduce the
standard;exceptfordistance,inwhichcaseinchesareusedand antimicrobial activity, or through the use of chemical agents,
metric units follow in parentheses.
called neutralizers, to eliminate antibacterial activity.
1.6 This standard does not purport to address all of the 3.1.5 resident microorganisms, n—microorganisms that live
safety concerns, if any, associated with its use. It is the
and multiply on the skin, forming a permanent population.
responsibility of the user of this standard to establish appro-
3.1.6 test formulation, n—a formulation which incorporates
priate safety and health practices and determine the applica-
antimicrobial ingredient(s).
bility of regulatory limitations prior to use. For more specific
3.1.7 test organism—an applied inoculum of an organism
precautionary statements see 8.2.
that has characteristics which allow it to be readily identified.
The test organism is used to simulate a transient topical
2. Referenced Documents
microbial contaminant. It may also be referred to as a marker
3
2.1 ASTM Standards:
organism, bacterial simulant, or bacterial contaminant.
E1054Test Methods for Evaluation of Inactivators of Anti-
3.1.8 transient microorganisms—organisms from the envi-
microbial Agents
ronment that contaminate but do not normally colonize the
E2755 Test Method for Determining the Bacteria-
skin.
Eliminating Effectiveness of Hand Sanitizer Formulations
Using Hands of Adults
4. Summary of Test Method
3. Terminology
4.1 This test method is conducted on a group of volunteer
3.1 Definitions: panelists who have refrained from using topical antimicrobial
formulations for at least one week prior to the initiation of the
1 test.Activity of the test material is measured by comparing the
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
number of test organisms recovered from artificially contami-
responsibility of Subcommittee E35.15Antimicrobial Agents.
nated hands after use of a handwashing formulation to the
Current edition approved Feb. 15, 2013. Published February 2013. Originally
numberrecoveredfromcontaminatedhandsnotexposedtothe
approved in 1987. Last previous edition approved in 2006 as E1174–06. DOI:
test formulation. The method describes specific procedures to
10.1520/E1174-13.
2
Federal Register, Vol 46, No. 17, Jan. 27, 1991.
be followed using Serratia marcescens as the test organism.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
The activity of the test material is measured following a single
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
wash and may be measured following multiple washes in a
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. single day using a neutralization recovery method.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E1174 − 13
4.2 Analternativetestorganismis Escherichia coli.Culture constantlystirring.Addtheethanol
...

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 − 06 E1174 − 13
Standard Test Method for
Evaluation of the Effectiveness of Health Care 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. 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 covers the determination ofis designed to determine 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 In this test method, metric units are used for all applications, except for distance in which case inches are used and metric
units follow in parentheses.
1.3 This test method may be used to evaluate topical antimicrobial handwash formulations.
2
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 and health practices and determine the applicability of regulatory
limitations prior to use. For more specific precautionary statements see 8.2.
2. Referenced Documents
3
2.1 ASTM Standards:
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
E2755 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hand Sanitizer Formulations Using Hands of
Adults
3. Terminology
3.1 Definitions:
3.1.1 active ingredient—ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of
microorganisms.
3.1.2 cleansing wash—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.
3.1.3 healthcare personnel handwash—handwash, n—a cleanser or waterless agent intended to reduce transient bacteria on the
hands.
3.1.4 neutralization—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.
3.1.5 resident microorganisms—microorganisms, n—microorganisms that live and multiply on the skin, forming a permanent
population.
1
This test method is under the jurisdiction of ASTM Committee E35 on Pesticides Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15Antimicrobial Agents.
Current edition approved March 1, 2006Feb. 15, 2013. Published April 2006February 2013. Originally approved in 1987. Last previous edition approved in 20002006
as E1174 – 00.E1174 – 06. DOI: 10.1520/E1174-06.10.1520/E1174-13.
2
Federal Register, Vol 46, No. 17, Jan. 27, 1991.Jan. 27, 1991.
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 ----------------------
E1174 − 13
3.1.6 test formulation—formulation, n—a formulation which incorporates antimicrobial ingredient(s).
3.1.7 test organism—an applied inoculum of an organism that has characteristics which allow it to be readily identified. The test
organism is used to simulate a transient topical microbial contaminant. It may also be referred to as a marker organism, bacterial
simulant, or bacterial contaminant.
3.1.8 transient microorganisms—organisms from the environment that contaminate but do not normally colonize the skin.
4. Summary of Test Method
4.1 This test method is conducted on a group of volunteer panelists who have refrained from using topical antimicrobial
formulations for at least one week prior to the
...