ASTM E1173-15

Standard Test Method 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 organisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, to maintain reductions for an extended time.
SCOPE
1.1 The test method is designed to measure the reduction of the microflora of the skin.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3.1 Exception—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 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2  
1.5 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.

General Information

• Status: Historical
• Publication Date: 30-Apr-2015
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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 − 15
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. Terminology
3.1 Terms used in this standard are defined in E2756,
1.1 The test method is designed to measure the reduction of
Standard Terminology Relating to Antimicrobial and Antiviral
the microflora of the skin.
Agents. Others defined below are specific to their use in this
1.2 A knowledge of microbiological techniques is required
document.
for these procedures.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active ingredient, n—a substance added to a formula-
1.3 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this tion specifically for the inhibition or inactivation of microor-
ganisms.
standard.
1.3.1 Exception—In this test method, metric units are used 3.2.2 inguen, n—groin: the junctional region between the
abdomen and thigh; pl. inguina.
for all applications except for linear measure, in which case
inches are used, and metric units follow in parentheses.
3.2.3 inguinal crease—the discrete region of flexure be-
tween the abdomen and the thigh.
1.4 Performance of this procedure requires a knowledge of
2
3.2.4 sampling fluid—a recovery fluid that contains a neu-
regulations pertaining to the protection of human subjects (1).
tralizer demonstrated to inactivate or quench the active ingre-
1.5 This standard does not purport to address all of the
dient(s) in test and reference control formulations. See Test
safety problems, if any, associated with its use. It is the
Method E1054.
responsibility of the user of this standard to establish appro-
3.2.5 test formulation—a formulation containing an active
priate safety and health practices and determine the applica-
ingredient(s).
bility of regulatory limitations prior to use.
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
E2756 Terminology Relating to Antimicrobial and Antiviral
4.2 The antimicrobial activity of preoperative, vascular
Agents precatheterization, or preinjection skin preparations is mea-
sured by comparing microbial counts, obtained at various time
intervals after application of a test formulation to skin sites, to
counts obtained from those same sites prior to application of
1
This test method is under the jurisdiction of ASTM Committee E35 on
the test formulation. Skin sites recommended for use in testing
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents. are: (1) the inguinal region and the abdomen for preoperative
Current edition approved May 1, 2015. Published July 2015. Originally approved
skin preparations; (2) the inguinal region, the subclavian
in 1987. Last previous edition approved in 2009 as E1173 – 01(2009). DOI:
(clavicular) region, or the median cubital region of the arm for
10.1520/E1173-15.
2
vascular precatheterization preparations, or both; and (3) the
The boldface numbers in parentheses refer to the list of references at the end of
this standard.
median cubital region of the arm for preinjection skin prepa-
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
rations.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4.2.1 Preoperative Skin Preparation—Microbial samples
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. are collected from the test sites a minimum of three (3) times
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E1173 − 15
after treatment application on both moist and dry skin sites. 7.4 Rubber Policeman, TFE-fluorocarbon Scrubbers, or
The recommended sample times are 10 min, 30 min, and 6 h other appropriate advice—Can be fashioned in the laboratory
post-treatment, but other relevant
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM 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: E1173 − 01 (Reapproved 2009) E1173 − 15
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
1.1 The test method is designed to measure the reduction of the resident microbial flora microflora 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.The values stated in SI units are to be regarded as standard. No other units of measurement are
included in this standard.
1.3.1 Exception—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.
2
1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).
1.5 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.
2
1.5 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).
2. Referenced Documents
3
2.1 ASTM Standards:
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
E1874 Test Method for Recovery of Microorganisms From Skin using the Cup Scrub Technique
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
3. Terminology
3.1 active ingredient—a substance added Terms used in this standard are defined in E2756to a formulation specifically for the
inhibition or inactivation of microorganisms., Standard Terminology Relating to Antimicrobial and Antiviral Agents. Others
defined below are specific to their use in this document.
3.2 test formulation—a formulation containing an active ingredient(s).
3.2 Definitions of Terms Specific to This Standard:
3.2.1 active ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of microorganisms.
3.2.2 inguen, n—groin: the junctional region between the abdomen and thigh; pl. inguina.
3.2.3 inguinal crease—the discrete region of flexure between the abdomen and the thigh.
3.2.4 sampling fluid—a recovery fluid that contains a neutralizer demonstrated to inactivate or quench the active ingredient(s)
in test and reference control formulations. See Test Method E1054.
3.2.5 test formulation—a formulation containing an active ingredient(s).
3.3 internal reference formulation—a formulation with demonstrated performance characteristics within a specific 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 approved Oct. 1, 2009May 1, 2015. Published November 2009July 2015. Originally approved in 1987. Last previous edition approved in 20012009 as
ε1
E1173 – 01 .(2009). DOI: 10.1520/E1173-01R09.10.1520/E1173-15.
2
The boldface numbers in parentheses refer to the list of references at the end of this standard.standard.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1173 − 15
3.4 sampling fluid—a recovery fluid that may or may not contain a neutralizer to inactivate the active ingredient(s) in test and
internal reference formulations.
3.5 persistence—prolonged or extended antimicrobial activity after treatment that prevents or inhibits the proliferation and/or
survival of microorganisms.
3.6 neutralization—a process that results in quenching the antimicrobial activity of a formulation. This may be achieved through
diluti
...