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ASTM E1173-01(2009)

(Test Method)

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

Standard Test Method for Evaluation of 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 of regulations pertaining to the protection of human subjects (1).

General Information

Status
Historical
Publication Date
30-Sep-2009
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 E1173-01e1 - Standard Test Method of a Evaluation of a 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
01-Oct-2009
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
01-Oct-2009

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ASTM E1173-01(2009) - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin PreparationsASTM E1173-01(2009) - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
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ASTM E1173-01(2009) - Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
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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: E1173 − 01(Reapproved 2009)
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. Scope 3.3 internal reference formulation—a formulation with
demonstrated performance characteristics within a specific
1.1 The test method is designed to measure the reduction of
laboratory.
the resident microbial flora of the skin.
3.4 sampling fluid—a recovery fluid that may or may not
1.2 A knowledge of microbiological techniques is required
containaneutralizertoinactivatetheactiveingredient(s)intest
for these procedures.
and internal reference formulations.
1.3 In this test method, metric units are used for all
3.5 persistence—prolonged or extended antimicrobial activ-
applicationsexceptforlinearmeasure,inwhichcaseinchesare
ity after treatment that prevents or inhibits the proliferation
used, and metric units follow in parentheses.
and/or survival of microorganisms.
1.4 This standard does not purport to address all of the
3.6 neutralization—a process that results in quenching the
safety problems, if any, associated with its use. It is the
antimicrobial activity of a formulation. This may be achieved
responsibility of the user of this standard to establish appro-
through dilution of the formulation to reduce the antimicrobial
priate safety and health practices and determine the applica-
activity, or through use of chemical agents, called neutralizers,
bility of regulatory limitations prior to use.
to curtail antimicrobial activity.
1.5 Performance of this procedure requires a knowledge of
2
regulations pertaining to the protection of human subjects (1).
4. Summary of Test Method
2. Referenced Documents
4.1 These test methods are conducted on human subjects
3
selected randomly from a group of volunteers who, after
2.1 ASTM Standards:
refraining voluntarily from using topical and oral antimicrobi-
E1054 Test Methods for Evaluation of Inactivators of Anti-
als for at least two weeks (14 days), exhibit acceptably high
microbial Agents
normal flora counts on the skin sites to be used in testing (see
E1874 Test Method for Recovery of Microorganisms From
Section 8).
Skin using the Cup Scrub Technique
4.2 The antimicrobial activity of the preoperative,
3. Terminology
precatheterization, or preinjection skin preparations is mea-
3.1 active ingredient—a substance added to a formulation sured by comparing microbial counts, obtained at various time
specifically for the inhibition or inactivation of microorgan- intervals after application of a test formulation to skin sites, to
isms. counts obtained from those same sites prior to application of
the test formulation. Skin sites recommended for use in testing
3.2 test formulation—a formulation containing an active
are: 1) the inguinal region and the abdomen for preoperative
ingredient(s).
skin preparations; 2) the inguinal region, the subclavian (clav-
icular) region, and/or the median cubital region of the arm for
precatheterization preparations; and 3) the median cubital
1
This test method is under the jurisdiction of ASTM Committee E35 on
region of the arm for preinjection skin preparations.
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents. 4.2.1 Preoperative Skin Preparation—Microbial samples
Current edition approved Oct. 1, 2009. Published November 2009. Originally
are collected from the test sites a minimum of 3 times after
ϵ1
approved in 1987. Last previous edition approved in 2001 as E1173 – 01 . DOI:
treatment application on both moist and dry skin sites. The
10.1520/E1173-01R09.
2
sample times are 10 min, 30 min, and 6 h (or other appropriate
The boldface numbers in parentheses refer to the list of references at the end of
this standard.
times) post-treatment.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.2.2 Precatheterization Preparation—Microbial samples
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
the ASTM website. treatment application on both moist and dry skin sites. The
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1173 − 01 (2009)
4
sample times are “immediate,” 12 h, and 24 h p
...

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Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

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.
SCOPE
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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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