ASTM E1874-22

Standard Test Method 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 E2752). Examples of test materials, for which this method 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 test method 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: Historical
• 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)

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: E1874 − 22
Standard Test Method 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.
1. Scope E2756 Terminology Relating to Antimicrobial and Antiviral
Agents
1.1 This test method is designed to recover microorganisms
3
2.2 Federal Document:
from the skin of human subjects or human subject surrogates
CFR Parts 50 and 56 Code of Federal Regulations: Protec-
(animal skin, isolated porcine skin, human skin equivalents,
tion of Human Subjects; Institutional Review Boards
and other such surfaces).
1.2 Knowledge of microbiological techniques is required
3. Terminology
for these procedures.
3.1 Defintions—For definitions of terms used in this
1.3 It is the responsibility of the investigator to determine if
document, see Terminology E2756.
Good Laboratory Practice (GLP) and Good Clinical Practice
3.2 Definitions of Terms Specific to This Standard:
(GCP) is required.
3.2.1 contralateral, adj—on or relating to the opposite side
1.4 The values stated in SI units are to be regarded as
(of the body).
standard. No other units of measurement are included in this
3.2.2 scrub cups, n—sterile cylinders of suitable composi-
standard.
tion (that is, glass, ceramic, stainless steel, plastic, etc.) used to
1.5 This standard does not purport to address all of the
isolate a sample area of skin (or skin equivalent) and confine a
safety concerns, if any, associated with its use. It is the
aliquot of liquid which is used to facilitate the scrubbing of the
responsibility of the user of this standard to establish appro-
skin and removal of microorganisms from the skin surface by
priate safety, health, and environmental practices and deter-
pipetting.
mine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accor- 4. Summary of Test Method
dance with internationally recognized principles on standard-
4.1 This test method describes a technique suitable for the
ization established in the Decision on Principles for the
recovery of resident and transient microorganisms from human
Development of International Standards, Guides and Recom-
or animal skin; the technique may be used in situ within
mendations issued by the World Trade Organization Technical
clinical protocols or in vitro for studies using isolated skin or
Barriers to Trade (TBT) Committee.
skin equivalents.
4.2 Resident and transient microorganisms and/or surrogate
2. Referenced Documents
microorganisms (previously applied to a test site) are recovered
2
2.1 ASTM Standards:
from the site by pressing a rigid cylinder against the skin with
E1054 Practices for Evaluation of Inactivators of Antimicro-
sufficient pressure to form a seal and instilling recovery liquid
bial Agents
into the cylinder. The surface of the skin is then mechanically
E2752 Guide for Evaluation of Residual Effectiveness of
‘scrubbed’ with a polished glass rod, rubber policeman, or
Antibacterial Personal Cleansing Products
some other suitable device for a prescribed period of time. The
fluid is pipetted from the cylinder into a test tube, or other
suitable receptacle, for further analysis.
1
This tests method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
5. Significance and Use
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Nov. 1, 2022. Published January 2023. Originally
5.1 The procedure can be incorporated into protocols used
approved in 1997. Last previous edition approved in 2014 as E1875–14. DOI:
to evaluate test materials containing antibacterial ingredients
10.1520/E1874-22.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1874 − 22
that are intended to reduce significantly the number of organ- 8.3.1 Test article control—A formula similar to that under
isms on intact skin. It also may be used to provide an indication test with antimicrobial ingredients removed
of residual antibacterial act
...

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: E1874 − 14 E1874 − 22
Standard Test Method 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.
1. Scope
1.1 This test method 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E2752 Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
3
2.2 Federal Document:
CFR Parts 50 and 56 Code of Federal Regulations: Protection of Human Subjects; Institutional Review Boards
3. Terminology
3.1 Defintions—For definitions of terms used in this document, see Terminology E2756.
1
This tests 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 April 1, 2014Nov. 1, 2022. Published April 2014January 2023. Originally approved in 1997. Last previous edition approved in 20092014 as
E1875–09.–14. DOI: 10.1520/E1874-14.10.1520/E1874-22.
2
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.
3
Available from DLA Document Services, Building 4/D, 700 Robbins Ave., Philadelphia, PA 19111-5094, http://quicksearch.dla.mil.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1874 − 22
3.2 Definitions of Terms Specific to This Standard:
3.2.1 contralateral, adj—on or relating to the opposite side (of the body).
3.1.2 resident flora, n—microorganisms that live and multiply on skin, forming a permanent population.
3.2.2 scrub cups, n—sterile cylinders of suitable composition (that is, glass, ceramic, stainless steel, plastic, etc.) used to isolate
a sample area of skin (or skin equivalent) and confine a aliquot of liquid which is used to facilitate the scrubbing of the skin and
removal of microorganisms from the skin surface by pipetting.
3.1.4 transient organisms, n—organisms from the environment that contaminate but do not normally colonize skin.
4. Summary of Test Method
4.1 This test method describes a technique suitable for the recovery of resident and transient microorganisms from human or
animal skin; the technique may be used in situ within clinical protocols or in vitro for studies using isolated skin or skin equivalents.
4.2 This test method describes a technique suitable for the recovery of resident Resident and transient microorganisms from human
or animal skin; the technique may be used in situ within clinical protocols and/or surrogate microorganisms (previously applied
to a test site) are recovered from the site by pressing a rigid cylinder against the skin with sufficient pressure to form a seal and
instilling recovery
...