ASTM E1115-11
(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 − 11
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.2 Other Documents:
3
21 CFRParts 50 and 56
1.1 Thistestmethodisdesignedtomeasurethereductionof
AATCC 147–2004Antibacterial Assessment 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 forAntimi-
microbial reductions, after single or repetitive treatments, or
5
crobial Activity and Efficacy
both. It may also be used to measure cumulative antimicrobial
USP32United States Pharmacopeia, Chapter 61 “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-
isms.
1.4 The values stated in SI units are to be regarded as
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
3.1.3 cleansing wash formulation—a liquid castile soap or
applications,exceptfordistance,inwhichcaseinchesareused
other liquid soap with neutral pH which does not contain an
and SI 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-
tory.
2. Referenced Documents
3.1.6 neutralization—a process that results in quenching or
2
2.1 ASTM Standards:
inactivationoftheantimicrobialactivityofaformulation.This
D1193Specification for Reagent Water
maybeachievedthroughdilutionoftheformulationorthrough
E1054Test Methods for Evaluation of Inactivators of Anti-
the use of chemical agents called neutralizers.
microbial Agents
3.1.7 persistence—prolonged or extended antimicrobial ac-
E2180Test Method for Determining the Activity of Incor-
tivity that prevents or inhibits the proliferation or survival of
porated Antimicrobial Agent(s) In Polymeric or Hydro-
microorganisms after treatment.
phobic Materials
3
Available from U.S. Government Printing Office, 732 N. Capitol St.,
1
This test method is under the jurisdiction of ASTM Committee E35 on Washington, DC 20401, U.S. Government Bookstore, http://bookstore.gpo.gov/
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct baskets/cfr-listing.jsp.
4
responsibility of Subcommittee E35.15 on Antimicrobial Agents. Technical Manual of the American Association of Textile Chemists and
Current edition approved Aug. 1, 2011. Published August 2011. Originally Colorists (AATCC), 2009, Vol 82, P.O. Box 12215, Research Triangle Park, NC
approved in 1986. Last previous edition approved in 2010 as E1115–10. DOI: 27709, http://www.aatcc.org.
5
10.1520/E1115-11. 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 AvailablefromU.S.Pharmacopeia(USP),12601TwinbrookPkwy.,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
---------------------- Page: 1 ----------------------
E1115 − 11
3.1.8 sampling fluid—a buffered solution that aids in recov- 6.5 Hand Washing Sink—Asink of sufficient size to permit
ery of microorganisms from the skin and neutralization of the subjec
...
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:E1115–10 Designation:E1115–11
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.
1.3 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
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
4
AATCC 147–2004 Antibacterial Assessment of Textile Materials: Parallel Streak Method
5
JIS Z 2801 :2000, Antimicrobial Products—Test for Antimicrobial Activity and Efficacy
6
USP 32 United States Pharmacopeia, Chapter 61 “Microbial Limits Test”, 2009
3. Terminology
3.1 Definitions:
3.1.1 active ingredient—a substance added to a formulation specifically for the inhibition or inactivation of microorganisms.
3.1.2 cleansing wash—a non-antimicrobial wash intended to remove gross soil or residues from the hands.
3.1.3 cleansing wash formulation—a liquid castile soap or other liquid soap with neutral pH which does not contain an
antimicrobial.
3.1.4 cumulative effect—a progressive decrease in the number of microorganisms recovered following repeated applications.
3.1.5 internal reference formulation—a formulation with demonstrated performance characteristics within the laboratory.
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 E35.15 on Antimicrobial Agents.
Current edition approvedAprilAug. 1, 2010.2011. PublishedAugust 2010.2011. Originally approved in 1986. Last previous edition approved in 20022010 as E1115 – 102.
DOI: 10.1520/E1115-101.
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
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
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
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.
6
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, 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
---------------------- Page: 1 ----------------------
E1115 – 11
3.1.6 neutralization—a process that results in quenching or inactivation of the antimicrobial activity of a formulation.This may
be achieved through dilution of the formulation or through the use of chemical agents called neutralizers.
3.1.7 per
...
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