ASTM E1874-22e1

Standard Practice for Recovery of Microorganisms From Skin using the Cup Scrub Technique

SIGNIFICANCE AND USE
5.1 The procedure can be incorporated into protocols used to evaluate test materials containing antibacterial ingredients that are intended to reduce significantly the number of organisms on intact skin. It also may be used to provide an indication of residual antibacterial activity (as in Guide E2752). Examples of test materials, for which this practice is applicable, include pre-operative skin preparations, hand-washes, surgical scrubs, acne reduction products, and others. For each type of test material, types of resident flora or surrogate organisms, or a combination thereof, may differ and should be considered (this is, aerobic bacteria, anaerobic bacteria, yeast, or mold).  
5.2 The procedure may be used in protocols intended to evaluate and identify resident flora from the skin.  
5.3 Performance of this technique may require the knowledge of regulations pertaining to the protection of human subjects if the protocol involves application of the technique to the skin of human subjects.
SCOPE
1.1 This practice is designed to recover microorganisms from the skin of human subjects or human subject surrogates (animal skin, isolated porcine skin, human skin equivalents, and other such surfaces).  
1.2 Knowledge of microbiological techniques is required for these procedures.  
1.3 It is the responsibility of the investigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) is required.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Oct-2022
• ICS: 71.100.40 - Surface active agents
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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Designation: E1874 − 22
Standard Practice for
Recovery of Microorganisms From Skin using the Cup
1
Scrub Technique
This standard is issued under the fixed designation E1874; 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.
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ε NOTE—The standard type was editorially corrected in April 2023.
1. Scope E2752 Guide for Evaluation of Residual Effectiveness of
Antibacterial Personal Cleansing Products
1.1 This practice is designed to recover microorganisms
E2756 Terminology Relating to Antimicrobial and Antiviral
from the skin of human subjects or human subject surrogates
Agents
(animal skin, isolated porcine skin, human skin equivalents,
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2.2 Federal Document:
and other such surfaces).
CFR Parts 50 and 56 Code of Federal Regulations: Protec-
1.2 Knowledge of microbiological techniques is required
tion of Human Subjects; Institutional Review Boards
for these procedures.
1.3 It is the responsibility of the investigator to determine if 3. Terminology
Good Laboratory Practice (GLP) and Good Clinical Practice
3.1 Defintions—For definitions of terms used in this
(GCP) is required.
document, see Terminology E2756.
1.4 The values stated in SI units are to be regarded as
3.2 Definitions of Terms Specific to This Standard:
standard. No other units of measurement are included in this
3.2.1 contralateral, adj—on or relating to the opposite side
standard.
(of the body).
1.5 This standard does not purport to address all of the
3.2.2 scrub cups, n—sterile cylinders of suitable composi-
safety concerns, if any, associated with its use. It is the
tion (that is, glass, ceramic, stainless steel, plastic, etc.) used to
responsibility of the user of this standard to establish appro-
isolate a sample area of skin (or skin equivalent) and confine a
priate safety, health, and environmental practices and deter-
aliquot of liquid which is used to facilitate the scrubbing of the
mine the applicability of regulatory limitations prior to use.
skin and removal of microorganisms from the skin surface by
1.6 This international standard was developed in accor-
pipetting.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
4. Summary of Practice
Development of International Standards, Guides and Recom-
4.1 This practice describes a technique suitable for the
mendations issued by the World Trade Organization Technical
recovery of resident and transient microorganisms from human
Barriers to Trade (TBT) Committee.
or animal skin; the technique may be used in situ within
clinical protocols or in vitro for studies using isolated skin or
2. Referenced Documents
skin equivalents.
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2.1 ASTM Standards:
4.2 Resident and transient microorganisms and/or surrogate
E1054 Practices for Evaluation of Inactivators of Antimicro-
microorganisms (previously applied to a test site) are recovered
bial Agents
from the site by pressing a rigid cylinder against the skin with
sufficient pressure to form a seal and instilling recovery liquid
into the cylinder. The surface of the skin is then mechanically
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This practice is under the jurisdiction of ASTM Committee E35 on Pesticides,
‘scrubbed’ with a polished glass rod, rubber policeman, or
Antimicrobials, and Alternative Control Agents and is the direct responsibility of
some other suitable device for a prescribed period of time. The
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Nov. 1, 2022. Published January 2023. Originally
fluid is pipetted from the cylinder into a test tube, or other
approved in 1997. Last previous edition approved in 2014 as E1875–14. DOI:
suitable receptacle, for further analysis.
10.1520/E1874-22E01.
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
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Standards volume information, refer to the standard’s Document Summary page on Available from DLA Document Services, Building 4/D, 700 Robbins Ave.,
the ASTM website. Philadelphia, PA 19111-5094, http://quicksearch.dla.mil.
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E1874 − 22
5. Significance and Use 8.3 While designing a study following this practice, proper
controls must be taken into consideration. Some examples are:
5.1 The procedure can be incorporated into protocol
...