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ASTM E1173-01e1

(Test Method)

Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations

Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations

SIGNIFICANCE AND USE
These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting and to reduce significantly the number of organisms on intact skin immediately and, for preoperative and precatheterization preparations, to maintain reductions for an extended time.
SCOPE
1.1 The test method is designed to measure the reduction of the resident microbial flora of the skin.
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 linear measure, in which case inches are used, and metric units follow in parentheses.
1.4 This standard does not purport to address all of the safety problems, 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.
1.5 Performance of this procedure requires a knowledge os regulations pertaining to the protection of human subjects (1).

General Information

Status
Historical
Publication Date
09-Apr-2001
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 E1173-01 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
Effective Date
10-Apr-2001
Replaced By
ASTM E1173-01(2009) - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
Effective Date
01-Oct-2009
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
10-Apr-2001
Referred By
ASTM E2613-23 - Standard Practice for Determining the Fungus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults
Effective Date
10-Apr-2001

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ASTM E1173-01e1 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin PreparationsASTM E1173-01e1 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
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ASTM E1173-01e1 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
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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
´1
Designation:E1173–01
Standard Test Method for
Evaluation of Preoperative, Precatheterization, or
1
Preinjection Skin Preparations
This standard is issued under the fixed designation E1173; 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
´ NOTE—The title was editorially updated in March 2002.
1. Scope 3.2 test formulation—a formulation containing an active
ingredient(s).
1.1 The test method is designed to measure the reduction of
3.3 internal reference formulation—a formulation with
the resident microbial flora of the skin.
demonstrated performance characteristics within a specific
1.2 A knowledge of microbiological techniques is required
laboratory.
for these procedures.
3.4 sampling fluid—a recovery fluid that may or may not
1.3 In this test method, metric units are used for all
containaneutralizertoinactivatetheactiveingredient(s)intest
applicationsexceptforlinearmeasure,inwhichcaseinchesare
and internal reference formulations.
used, and metric units follow in parentheses.
3.5 persistence—prolongedorextendedantimicrobialactiv-
1.4 This standard does not purport to address all of the
ity after treatment that prevents or inhibits the proliferation
safety problems, if any, associated with its use. It is the
and/or survival of microorganisms.
responsibility of the user of this standard to establish appro-
3.6 neutralization—a process that results in quenching the
priate safety and health practices and determine the applica-
antimicrobial activity of a formulation. This may be achieved
bility of regulatory limitations prior to use.
through dilution of the formulation to reduce the antimicrobial
1.5 Performance of this procedure requires a knowledge of
2
activity, or through use of chemical agents, called neutralizers,
regulations pertaining to the protection of human subjects (1).
to curtail antimicrobial activity.
2. Referenced Documents
4. Summary of Test Method
3
2.1 ASTM Standards:
4.1 These test methods are conducted on human subjects
E1054 Test Methods for Evaluation of Inactivators of An-
selected randomly from a group of volunteers who, after
timicrobial Agents
refraining voluntarily from using topical and oral antimicrobi-
E1874 Test Method for Evaluation of Antibacterial Washes
4 als for at least two weeks (14 days), exhibit acceptably high
by Cup Scrub Technique
normal flora counts on the skin sites to be used in testing (see
3. Terminology Section 8).
4.2 The antimicrobial activity of the preoperative, precath-
3.1 active ingredient—a substance added to a formulation
eterization, or preinjection skin preparations is measured by
specifically for the inhibition or inactivation of microorgan-
comparing microbial counts, obtained at various time intervals
isms.
after application of a test formulation to skin sites, to counts
obtained from those same sites prior to application of the test
1
This test method is under the jurisdiction of ASTM Committee E35 on
formulation. Skin sites recommended for use in testing are: 1)
Pesticides and is the direct responsibility of Subcommittee E35.15 onAntimicrobial
the inguinal region and the abdomen for preoperative skin
Agents.
preparations; 2) the inguinal region, the subclavian (clavicular)
Current edition approved April 10, 2001. Published July 2001. Originally
published as E1173 – 87. Last previous edition E1173 – 93. DOI: 10.1520/E1173-
region, and/or the median cubital region of the arm for
01E01.
precatheterization preparations; and 3) the median cubital
2
The boldface numbers in parentheses refer to the list of references at the end of
region of the arm for preinjection skin preparations.
this standard.
3
4.2.1 Preoperative Skin Preparation—Microbial samples
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
are collected from the test sites a minimum of 3 times after
Standards volume information, refer to the standard’s Document Summary page on
treatment application on both moist and dry skin sites. The
the ASTM website.
4 sample times are 10 min, 30 min, and 6 h (or other appropriate
Withdrawn. The last approved version of this historical standard is referenced
on www.astm.org. times) post-treatment.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
´1
E1173–01
5
4.2.2 Precatheterization Preparation—Microbial samples 7.7 Sterile Drape or Dressing —Used to cover treated skin
are collected from the test sites a minimum of 3 times
...

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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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SIGNIFICANCE AND USE
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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