ASTM E1874-09

Standard Test Method for Recovery of Microorganisms from Skin using the Cup Scrub Technique

SIGNIFICANCE AND USE
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.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Sep-2009
• ICS: 71.100.40 - Surface active agents
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E1874-97 - Standard Test Method for Evaluation of Antibacterial Washes by Cup Scrub Technique (Withdrawn 2006)
• Effective Date: 01-Oct-2009
• Referred By: ASTM E1589-21 - Standard Practice for Evaluation of First Aid Antiseptic Drug Products
• Effective Date: 01-Oct-2009
• Referred By: ASTM E2897-22 - Standard Guide for Evaluation of the Effectiveness of Hand Hygiene Topical Antimicrobial Products using <emph type="bdit">ex vivo</emph> Porcine Skin
• Effective Date: 01-Oct-2009
• Referred By: ASTM E2752-10(2015) - Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
• Effective Date: 01-Oct-2009
• Referred By: ASTM E1173-23 - Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
• Effective Date: 01-Oct-2009

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 − 09
StandardTest 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 3.1.3 scrub cups, n—sterile cylinders of suitable composi-
tion (that is, glass, ceramic, stainless steel, plastic, etc.) used to
1.1 This test method is designed to recover microorganisms
isolate a sample area of skin (or skin equivalent) and confine a
from the skin of human subjects or human subject surrogates
aliquot of liquid which is used to facilitate the scrubbing of the
(animal skin, isolated porcine skin, human skin equivalents,
skin and removal of microorganisms from the skin surface by
and other such surfaces).
pipetting.
1.2 Knowledge of microbiological techniques is required
3.1.4 transient organisms, n—organisms from the environ-
for these procedures.
ment that contaminate but do not normally colonize skin.
1.3 It is the responsibility of the investigator to determine if
4. Summary of Test Method
Good Laboratory Practice (GLP) and Good Clinical Practice
(GCP) is required.
4.1 This test method describes a technique suitable for the
recovery of resident and transient microorganisms from human
1.4 The values stated in SI units are to be regarded as
or animal skin; the technique may be used in situ within
standard. No other units of measurement are included in this
clinical protocols or in vitro for studies using isolated skin or
standard.
skin equivalents.
1.5 This standard does not purport to address all of the
4.1.1 Resident microorganisms or transient microorganisms
safety concerns, if any, associated with its use. It is the
(previously applied to a test site), are recovered from the site
responsibility of the user of this standard to establish appro-
by pressing a rigid cylinder against the skin with sufficient
priate safety and health practices and determine the applica-
pressure to form a seal and instilling recovery liquid into the
bility of regulatory limitations prior to use.
cylinder. The surface of the skin is then mechanically
‘scrubbed’ with a glass rod, rubber policeman, or some other
2. Referenced Documents
suitable device for a prescribed period of time. The fluid is
2
2.1 ASTM Standards:
pipetted from the cylinder into a test tube, or other suitable
E1054 Test Methods for Evaluation of Inactivators of Anti-
receptacle, for further analysis.
microbial Agents
5. Significance and Use
3. Terminology 5.1 The procedure can be incorporated into protocols used
to evaluate test materials containing antibacterial ingredients
3.1 Definitions of Terms Specific to This Standard:
that are intended to reduce significantly the number of organ-
3.1.1 contralateral, adj—on or relating to the opposite side
ismsonintactskin.Italsomaybeusedtoprovideanindication
(of the body).
of residual antibacterial activity.
3.1.2 resident flora, n—microorganisms that live and mul-
5.2 Performance of this technique may require the knowl-
tiply on skin, forming a permanent population.
edge of regulations pertaining to the protection of human
subjects if the protocol involves application of the technique to
the skin of human subjects.
1
This tests method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
6. Apparatus
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
6.1 Sterilizer—Any suitable steam sterilizer capable of pro-
Current edition approved Oct. 1, 2009. Published October 2009. Originally
approvedin1997.Lastpreviouseditionapprovedin1997asE1874 – 97,whichwas
ducing the conditions of sterilization.
withdrawn January 2006 and reinstated in October 2009. DOI: 10.1520/E1874-09.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
7. Reagents and Materials
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
7.1 Scrub Cups—Sterile cylinders of suitable composition,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. preferably with rod handles to facilitate stabilization, height
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1874 − 09
approximately 2.5 cm, inside diameter of convenient size. pipette into a sterile sample tube. This procedure is repeated
Useful sizes range from approximately 1.5 to 4.0 cm. once more with a fresh aliquot of sampling fluid.The sampling
fluids are pool
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:E 1874–97 Designation:E1874–09
Standard Test Method for
Evaluation of Antibacterial Washes by Cup Scrub
TechniqueRecovery of Microorganisms From Skin using the
1
Cup 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
1.1This test method is designed to demonstrate the effectiveness of an antibacterial wash product in reducing the resident
microbial flora or a marker organism (representing transients) when used as recommended. Microbial activity can be compared
with either a bland soap control or to a baseline organism count. Microbial samples can be collected either manually or by the
mechanical Thran spray gun sampler.
1.2A knowledge of microbiological techniques is required for these procedures.
1.3In this test method, metric units are used for all applications.
1.4
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 and health practices and determine the applicability of regulatory
limitations prior to use.
1.5It is the responsibility of the investigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
is required.
2. Referenced Documents
2
2.1 ASTM Standards:
E1054 Practices for Evaluating Inactivators of Antimicrobial Agents Used in Disinfectant, Sanitizer, Antiseptic, or Preserved
Products
E1173Test Method for Evaluation of a Pre-Operative Skin Preparation Test Methods for Evaluation of Inactivators of
Antimicrobial Agents
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 bland control soapcontralateral, n—a formulation that does not exhibit antimicrobial activity under the test parameters.
adj—on or relating to the opposite side (of the body).
3.1.2 marker organismresident flora, n—an applied inoculum of an organism that has characteristics that allow it to be readily
identified or differentiated. Marker organisms are used to simulate transient microorganisms. It also is referred to as a simulant or
bacterial contaminant. —microorganisms that live and multiply on skin, forming a permanent population.
3.1.3 resident florascrub cups, n—microorganisms that live and multiply on skin, forming a permanent population. —sterile
1
ThistestsmethodisunderthejurisdictionofASTMCommitteeE35onPesticidesandAlternativeControlAgentsandisthedirectresponsibilityofSubcommitteeE35.15
on Antimicrobial Agents.
Current edition approved April 10, 1997. Published December 1997.
CurrenteditionapprovedOct.1,2009.PublishedOctober2009.Originallyapprovedin1997.Lastpreviouseditionapprovedin1997asE1874 – 97,whichwaswithdrawn
January 2006 and reinstated in October 2009. DOI: 10.1520/E1874-09.
2
Thran spray gun bacterial sampler may be obtained through Dr. Volker Thran, Kommission der Europaischen Gemeinschaften, Rue de la Loi 200, B-1049 Brussel,
Belgium.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
E1874–09
cylinders of suitable composition (that is, glass, ceramic, stainless steel, plastic, etc.) used to isolate a sample area of skin (or skin
equivalent)andconfineaaliquotofliquidwhichisusedtofacilitatethescrubbingoftheskinandremovalofmicroorganismsfrom
the skin surface by pipetting.
3.1.4 transient organisms, n—organismsfromtheenvironmentthatcontaminatebutdonotnormall
...