ASTM E1173-01

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

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
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E1173-93 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
• Effective Date: 10-Apr-2001
• Replaced By: ASTM E1173-01e1 - Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations
• Effective Date: 10-Apr-2001
• 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

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: E 1173 – 01
Standard Test Method for
Evaluation of a Preoperative, Precatheterization, or
1
Preinjection Skin Preparations
This standard is issued under the fixed designation E 1173; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.5 persistence—prolonged or extended antimicrobial activ-
ity after treatment that prevents or inhibits the proliferation
1.1 The test method is designed to measure the reduction of
and/or survival of microorganisms.
the resident microbial flora of the skin.
3.6 neutralization—a process that results in quenching the
1.2 A knowledge of microbiological techniques is required
antimicrobial activity of a formulation. This may be achieved
for these procedures.
through dilution of the formulation to reduce the antimicrobial
1.3 In this test method, metric units are used for all
activity, or through use of chemical agents, called neutralizers,
applications except for linear measure, in which case inches are
to curtail antimicrobial activity.
used, and metric units follow in parentheses.
1.4 This standard does not purport to address all of the
4. Summary of Test Method
safety problems, if any, associated with its use. It is the
4.1 These test methods are conducted on human subjects
responsibility of the user of this standard to establish appro-
selected randomly from a group of volunteers who, after
priate safety and health practices and determine the applica-
refraining voluntarily from using topical and oral antimicrobi-
bility of regulatory limitations prior to use.
als for at least two weeks (14 days), exhibit acceptably high
1.5 Performance of this procedure requires a knowledge of
2 normal flora counts on the skin sites to be used in testing (see
regulations pertaining to the protection of human subjects (1).
Section 8).
2. Referenced Documents 4.2 The antimicrobial activity of the preoperative, precath-
eterization, or preinjection skin preparations is measured by
2.1 ASTM Standards:
comparing microbial counts, obtained at various time intervals
E 1054 Practices for Evaluating Inactivators of Antimicro-
after application of a test formulation to skin sites, to counts
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or
3
obtained from those same sites prior to application of the test
Preserved Products
formulation. Skin sites recommended for use in testing are: 1)
E 1874 Test Method for Evaluation of Antibacterial Washes
3
the inguinal region and the abdomen for preoperative skin
by Cup Scrub Technique
preparations; 2) the inguinal region, the subclavian (clavicular)
3. Terminology
region, and/or the median cubital region of the arm for
precatheterization preparations; and 3) the median cubital
3.1 active ingredient—a substance added to a formulation
region of the arm for preinjection skin preparations.
specifically for the inhibition or inactivation of microorgan-
4.2.1 Preoperative Skin Preparation—Microbial samples
isms.
are collected from the test sites a minimum of 3 times after
3.2 test formulation—a formulation containing an active
treatment application on both moist and dry skin sites. The
ingredient(s).
sample times are 10 min, 30 min, and 6 h (or other appropriate
3.3 internal reference formulation—a formulation with
times) post-treatment.
demonstrated performance characteristics within a specific
4.2.2 Precatheterization Preparation—Microbial samples
laboratory.
are collected from the test sites a minimum of 3 times after
3.4 sampling fluid—a recovery fluid that may or may not
treatment application on both moist and dry skin sites. The
contain a neutralizer to inactivate the active ingredient(s) in test
sample times are “immediate,” 12 h, and 24 h post-treatment.
and internal reference formulations.
The immediate sample may be 30 sec to 10 min, depending on
the test material being evaluated.
1
This test method is under the jurisdiction of ASTM Committee E35 on
4.2.3 Preinjection Preparation—A microbial sample is col-
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial
lected from the test site 30 sec post-treatment.
Agents.
Current edition approved April 10, 2001. Published July 2001. Originally
4.3 The fluid used for sampling the test sites must effec-
published as E 1173 – 87. Last previous edition E 1173 – 93.
tively quench (neutralize) the antimicrobial action of all
2
The boldface numbers in parentheses refer to the list of references at the end of
formulations tested. The effectiveness of the inactivator must
this standard.
3
Annual Book of ASTM Standards, Vol 11.05. be demonstrated prior to initi
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