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ASTM E1327-07

(Test Method)

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

SIGNIFICANCE AND USE
The procedure should be used to test the degerming effectiveness of antimicrobial hand washing products used by health care personnel that are intended for frequent use, and that are intended to reduce the level of contamination acquired through contact with contaminated objects or people.
Performance of these procedures requires the knowledge of regulations pertaining to the protection of human subjects (Ref 1).3
SCOPE
1.1 This test method can be used to determine the effectiveness of antimicrobial handwashing agents (including handrubs) in the reduction of transient bacterial flora with particular emphasis on the fingernail region.
1.2 A knowledge of microbiological techniques is required for these procedures.
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 hazard statements, see 7.5.

General Information

Status
Historical
Publication Date
31-Mar-2007
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaces
ASTM E1327-90(2000) - Standard Test Method for Evaluation of Health Care Personnel Handwash Formulations by Utilizing Fingernail Regions
Effective Date
01-Apr-2007
Replaced By
ASTM E1327-07(2012)e1 - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
Effective Date
01-Oct-2012
Referred By
ASTM E2361-13(2021) - Standard Guide for Testing Leave-On Products Using In-Situ Methods
Effective Date
01-Apr-2007

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ASTM E1327-07 - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail RegionsASTM E1327-07 - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
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ASTM E1327-07 - Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions
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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: E1327 − 07
StandardTest Method for
Evaluation of Antimicrobial Handwash Formulations by
1
Utilizing Fingernail Regions
This standard is issued under the fixed designation E1327; 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 hands with a nonantimicrobial hand soap prior to testing to
remove any residual hand lotions and to lower the numbers of
1.1 This test method can be used to determine the effective-
resident skin flora. Activity of products is measured by
nessofantimicrobialhandwashingagents(includinghandrubs)
comparing the numbers of marker bacteria recovered from
in the reduction of transient bacterial flora with particular
artificially contaminated fingernail regions after use of the
emphasis on the fingernail region.
handwashing formulations to the numbers recovered from the
1.2 A knowledge of microbiological techniques is required
artificially contaminated but unwashed fingernail regions.
for these procedures.
Broth cultures of Serratia marcescens (a red pigmented bac-
1.3 This standard does not purport to address all of the
terial species) and Escherichia coli (which produces fluores-
safety concerns, if any, associated with its use. It is the cent colonies on a special agar medium) are used as test
responsibility of the user of this standard to establish appro-
bacteria. A spore suspension of Bacillus subtilis may be
priate safety and health practices and determine the applica- utilized to study (1) degree of physical removal by handwash-
bility of regulatory limitations prior to use. For more specific
ing techniques, and (2) the recovery and precision aspects of
hazard statements, see 7.5. the test method.
2. Referenced Documents
4. Significance and Use
2
2.1 ASTM Standards:
4.1 The procedure should be used to test the degerming
E1054 Test Methods for Evaluation of Inactivators of Anti-
effectiveness of antimicrobial hand washing products used by
microbial Agents
health care personnel that are intended for frequent use, and
E2276 Test Method for Determining the Bacteria-
that are intended to reduce the level of contamination acquired
Eliminating Effectiveness of Hygienic Handwash and
through contact with contaminated objects or people.
Handrub Agents Using the Fingerpads of Adults
4.2 Performance of these procedures requires the knowl-
E1838 Test Method for Determining the Virus-Eliminating
edge of regulations pertaining to the protection of human
Effectiveness of Hygienic Handwash and HandrubAgents
3
subjects (Ref 1).
Using the Fingerpads of Adults
5. Apparatus
3. Summary of Test Method
5.1 Colony Counter—Any of several types may be used, for
3.1 This test method, involving an improved method of
example, Quebec Colony Counter.
recovering bacteria from hands, is used to study the effects of
antimicrobial handwashes including health care personnel
5.2 Incubators—One incubator capable of maintaining a
handwash products. The group of volunteer panelists need not
temperature of 25 6 2°C (this temperature required to ensure
refrain from using topical antimicrobials (such as deodorant
pigment production of Serratia); a second incubator capable of
soaps) before participating in the study.All subjects wash their
maintaining 37 6 2°C used for E. coli and B. subtilis
incubation is acceptable.
1 5.3 Water Bath—Capable of maintaining temperature of 80
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct 6 2°C for heat shocking of B. subtilis spores is needed.
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
5.4 Sterilizer—Any suitable steam sterilizer capable of pro-
Current edition approved April 1, 2007. Published June 2007. Originally
approved in 1990. Last previous edition approved in 2000 as E1327 – 90 (2000). ducing the conditions of sterilization is acceptable.
DOI: 10.1520/E1327-07.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The boldface numbers in parentheses refer to a list of references at the end of
the ASTM website. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1327 − 07
5.5 Timer—Any stop-watch that can be read in minutes and routine as the nonantimicrobial control (10.5); alcoholic lotion
seconds is required. type formulations are rubbed to
...

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5.1 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of microorganisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, maintenance of some degree of reduction for an extended time.
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