ASTM E1174-06

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

SIGNIFICANCE AND USE
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.
SCOPE
1.1 This test method covers the determination of 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.
1.4 This test method may be used to evaluate topical antimicrobial handwash formulations.
1.5 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.
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 .

General Information

• Status: Historical
• Publication Date: 28-Feb-2006
• ICS: 71.100.40 - Surface active agents
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E1174-00 - Standard Test Method for Evaluation of the Effectiveness of Health Care Personnel or Consumer Handwash Formulations
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2755-22 - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2784-10(2015) - Standard Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of Hand Contamination
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2276-10(2019) - Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2361-13(2021) - Standard Guide for Testing Leave-On Products Using In-Situ Methods
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2946-21 - Standard Test Method for Determining the Bacteria-Reducing Effectiveness of Food-Handler Handwash Formulations Using Hands of Adults
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2897-22 - Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <emph type="bdit">ex vivo</emph> Porcine Skin
• Effective Date: 01-Mar-2006
• Referred By: ASTM E2870-19 - Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
• Effective Date: 01-Mar-2006

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 − 06
StandardTest 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 3.1.2 cleansing wash—a non-antimicrobial wash intended
toremovegrosssoilorresiduesfromthehandsofthepanelists
1.1 This test method covers the determination of the effec-
prior to the conduct of the study and as noted throughout the
tivenessofantimicrobialhandwashingagentsforthereduction
study. This may also be referred to as a cosmetic wash.
of transient microbial flora when used in a handwashing
3.1.3 healthcare personnel handwash—a cleanser or water-
procedure.
less agent intended to reduce transient bacteria on the hands.
1.2 A knowledge of microbiological techniques is required
3.1.4 neutralization—a process which results in quenching
for these procedures.
the antimicrobial activity of a test material. This may be
1.3 In this test method, metric units are used for all
achieved through dilution of the test material(s) to reduce the
applications, except for distance in which case inches are used
antimicrobial activity, or through the use of chemical agents,
and metric units follow in parentheses.
called neutralizers, to eliminate antibacterial activity.
1.4 This test method may be used to evaluate topical
3.1.5 resident microorganisms—microorganisms that live
antimicrobial handwash formulations.
and multiply on the skin, forming a permanent population.
1.5 Performance of this procedure requires the knowledge
3.1.6 test formulation—a formulation which incorporates
2
of regulations pertaining to the protection of human subjects.
antimicrobial ingredient(s).
1.6 This standard does not purport to address all of the
3.1.7 test organism—an applied inoculum of an organism
safety concerns, if any, associated with its use. It is the
that has characteristics which allow it to be readily identified.
responsibility of the user of this standard to establish appro-
The test organism is used to simulate a transient topical
priate safety and health practices and determine the applica-
microbial contaminant. It may also be referred to as a marker
bility of regulatory limitations prior to use. For more specific
organism, bacterial simulant, or bacterial contaminant.
precautionary statements see 8.2.
3.1.8 transient microorganisms—organisms from the envi-
ronment that contaminate but do not normally colonize the
2. Referenced Documents
skin.
3
2.1 ASTM Standards:
E1054Test Methods for Evaluation of Inactivators of Anti-
4. Summary of Test Method
microbial Agents
4.1 This test method is conducted on a group of volunteer
3. Terminology panelists who have refrained from using topical antimicrobial
formulations for at least one week prior to the initiation of the
3.1 Definitions:
test.Activityofthetestmaterialismeasuredbycomparingthe
3.1.1 active ingredient—a substance added to a formulation
number of test organisms recovered from artificially contami-
specifically for the inhibition or inactivation of microorgan-
nated hands after use of a handwashing formulation to the
isms.
numberrecoveredfromcontaminatedhandsnotexposedtothe
test formulation. The method describes specific procedures to
1
This test method is under the jurisdiction of ASTM Committee E35 on
be followed using Serratia marcescens as the test organism.
Pesticides and Alternative Control Agents and is the direct responsibility of
The activity of the test material may be measured following a
Subcommittee E35.15 Antimicrobial Agents.
Current edition approved March 1, 2006. Published April 2006. Originally
single wash and multiple washes in a single day using a
approved in 1987. Last previous edition approved in 2000 as E1174–00. DOI:
neutralization recovery method.
10.1520/E1174-06.
2
Federal Register, Vol 46, No. 17, Jan. 27, 1991.
4.2 Analternativetestorganismis Escherichia coli.Culture
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
media and incubation conditions appropriate for this organism
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
shouldbeemployed.Theinvestigatorshouldalsobeawarethat
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. there may be health risks associated with the use of this
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E1174 − 06
organism and precautions similar to those ref
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