ASTM E1115-10
(Test Method)Standard Test Method for Evaluation of Surgical Hand Scrub Formulations
Standard Test Method for Evaluation of Surgical Hand Scrub Formulations
SIGNIFICANCE AND USE
The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.
SCOPE
1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR, Parts 50 and 56)
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses.
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.
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Designation:E1115–10
Standard Test Method for
1
Evaluation of Surgical Hand Scrub Formulations
This standard is issued under the fixed designation E1115; 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 2.2 Other Documents:
3
21 CFR Parts 50 and 56
1.1 Thistestmethodisdesignedtomeasurethereductionof
AATCC 147–2004 AntibacterialAssessment of Textile Ma-
microbial flora on the skin. It is intended for determining both
4
terials: Parallel Streak Method
immediate and persistent (continuing antimicrobial effect)
JIS Z 2801 :2000, Antimicrobial Products—Test for Anti-
microbial reductions, after single or repetitive treatments, or
5
microbial Activity and Efficacy
both. It may also be used to measure cumulative antimicrobial
USP32 UnitedStatesPharmacopeia,Chapter61“Microbial
activity after repetitive treatments.
6
Limits Test”, 2009
1.2 A knowledge of microbiological techniques is required
for these procedures.
3. Terminology
1.3 Performance of this procedure requires the knowledge
3.1 Definitions:
of regulations pertaining to the protection of human subjects
3.1.1 active ingredient—a substance added to a formulation
(21 CFR, Parts 50 and 56)
specifically for the inhibition or inactivation of microorgan-
1.4 The values stated in SI units are to be regarded as
isms.
standard. No other units of measurement are included in this
3.1.2 cleansing wash—a non-antimicrobial wash intended
standard.
to remove gross soil or residues from the hands.
1.4.1 In this test method, SI units are used for all applica-
3.1.3 cleansing wash formulation—a liquid castile soap or
tions, except for distance, in which case inches are used and SI
other liquid soap with neutral pH which does not contain an
units follow in parentheses.
antimicrobial.
1.5 This standard does not purport to address all of the
3.1.4 cumulative effect—a progressive decrease in the num-
safety concerns, if any, associated with its use. It is the
ber of microorganisms recovered following repeated applica-
responsibility of the user of this standard to establish appro-
tions.
priate safety and health practices and determine the applica-
3.1.5 internal reference formulation—a formulation with
bility of regulatory limitations prior to use.
demonstrated performance characteristics within the labora-
2. Referenced Documents tory.
2 3.1.6 neutralization—a process that results in quenching or
2.1 ASTM Standards:
inactivation of the antimicrobial activity of a formulation. This
D1193 Specification for Reagent Water
maybeachievedthroughdilutionoftheformulationorthrough
E1054 Test Methods for Evaluation of Inactivators of An-
the use of chemical agents called neutralizers.
timicrobial Agents
3.1.7 persistence—prolonged or extended antimicrobial ac-
E2180 Test Method for Determining the Activity of Incor-
tivity that prevents or inhibits the proliferation or survival of
poratedAntimicrobialAgent(s)InPolymericorHydropho-
microorganisms after treatment.
bic Materials
3
Available from U.S. Government Printing Office, 732 N. Capitol St., Washing-
1
This test method is under the jurisdiction of ASTM Committee E35 on ton, DC 20401, U.S. Government Bookstore, http://bookstore.gpo.gov/baskets/cfr-
Pesticides and Alternative Control Agents and is the direct responsibility of listing.jsp.
4
Subcommittee E35.15 on Antimicrobial Agents. Technical Manual of the American Association of Textile Chemists and
Current edition approved April 1, 2010. Published August 2010. Originally Colorists (AATCC), 2009, Vol 82, P.O. Box 12215, Research Triangle Park, NC
approved in 1986. Last previous edition approved in 2002 as E1115 – 02. DOI: 27709, http://www.aatcc.org.
5
10.1520/E1115-10. Available from Japanese Industrial Standards Committee, Divisional Council
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or on Consumer Life, Japanese StandardsAssociation (JSA), 4-1-24Akasaka Minato-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Ku, Tokyo, 107-8440, Japan, http://www.jsa.or.jp.
6
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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E1115 – 10
3.1.8 sampling fluid—a buffered solution that aids in recov- 6.5.1 Water Faucet(s)—To be located above the sink at a
ery of microorganisms from the skin and neutralization of
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:E1115–02 Designation:E1115–10
Standard Test Method for
1
Evaluation of Surgical Hand Scrub Formulations
This standard is issued under the fixed designation E1115; 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 measure the reduction of microbial flora on the skin. It is intended for determining both
immediateandpersistent(continuingantimicrobialeffect)microbialreductions,aftersingleorrepetitivetreatments,orboth.Itmay
also be used to measure cumulative antimicrobial activity after repetitive treatments.
1.2 A knowledge of microbiological techniques is required for these procedures.
1.3In this method, metric units are used for all applications, except for distance, in which case inches are used and metric units
follow in parentheses.
1.4Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects.
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21
CFR, Parts 50 and 56)
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units
follow in parentheses.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D1193 Specification for Reagent Water
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents Test Methods for Evaluation of Inactivators of
Antimicrobial Agents
E2180 Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic
Materials
2.2 Other Documents:
3
21 CFR Parts 50 and 56
AATCC Test Method 1471993 Antibacterial Assessment of Textile Materials: Parallel Streak MethodAATCC 147–2004 An-
4
tibacterial Assessment of Textile Materials: Parallel Streak Method
5
JIS Z 2801 :2000, Antimicrobial Products—Test for Antimicrobial Activity and Efficacy
1
This test method is under the jurisdiction ofASTM Committee E35 on Pesticides andAlternative ControlAgents and is the direct responsibility of Subcommittee E35.15
on Antimicrobial Agents.
Current edition approved February 10, 2002. Published May 2002. Originally published as E1115–86. Discontinued June 2000 and reinstated with revision as E1115–02.
DOI: 10.1520/E1115-02.
Current edition approved April 1, 2010. Published August 2010. Originally approved in 1986. Last previous edition approved in 2002 as E1115 – 02. DOI:
10.1520/E1115-10.
2
21 CFR Ch. 1, Parts 50 and 56.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from U.S. Government Printing Office, 732 N. Capitol St., Washington, DC 20401, U.S. Government Bookstore, http://bookstore.gpo.gov/baskets/cfr-
listing.jsp.
4
United States Code of Federal Regulations.
4
Technical Manual of the American Association of Textile Chemists and Colorists (AATCC), 2009, Vol 82, P.O. Box 12215, Research Triangle Park, NC 27709,
http://www.aatcc.org.
5
Technical Manual of the American Association of Textile Chemists and Colorists, P.O. Box 12215, Research Triangle Park, NC 27709.
5
Available from Japanese Industrial Standards Committee, Divisional Council on Consumer Life, Japanese Standards Association (JSA), 4-1-24 Akasaka Minato-Ku,
Tokyo, 107-8440, Japan, http://www.jsa.or.jp.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1
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E1115 – 10
Horowitz, W. (Ed.), 2000, Offi
...
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