ASTM E1874-97

Standard Test Method for Evaluation of Antibacterial Washes by Cup Scrub Technique (Withdrawn 2006)

SCOPE
1.1 This 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.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 In this test method, metric units are used for all applications.  
1.4 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.  
1.5 It is the responsibility of the invesigator to determine if Good Laboratory Practice (GLP) and Good Clinical Practice (GLP) and Good Clinical Practice (GCP) is required.
WITHDRAWN RATIONALE
This 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.
Formerly under the jurisdiction of Committee E35 on Pesticides and Alternative Control Agents, this test method was withdrawn in January 2006 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Historical
• Publication Date: 31-Dec-1996
• Withdrawal Date: 31-Jan-2006
• ICS: 71.100.40 - Surface active agents
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaced By: ASTM E1874-09 - Standard Test Method for Recovery of Microorganisms from Skin using the Cup Scrub Technique
• 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-Jan-1997
• Referred By: ASTM E1589-21 - Standard Practice for Evaluation of First Aid Antiseptic Drug Products
• Effective Date: 01-Jan-1997
• Referred By: ASTM E2752-10(2015) - Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
• Effective Date: 01-Jan-1997
• Referred By: ASTM E1173-23 - Standard Practice for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations
• Effective Date: 01-Jan-1997

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:E1874–97
Standard Test Method for
Evaluation of Antibacterial Washes by Cup Scrub
1
Technique
This standard is issued under the fixed designation E 1874; 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 3.1.1 bland control soap, n—a formulation that does not
exhibit antimicrobial activity under the test parameters.
1.1 This test method is designed to demonstrate the effec-
3.1.2 marker organism, n—an applied inoculum of an
tiveness of an antibacterial wash product in reducing the
organism that has characteristics that allow it to be readily
resident microbial flora or a marker organism (representing
identified or differentiated. Marker organisms are used to
transients) when used as recommended. Microbial activity can
simulate transient microorganisms. It also is referred to as a
be compared with either a bland soap control or to a baseline
simulant or bacterial contaminant.
organism count. Microbial samples can be collected either
2 3.1.3 resident flora, n—microorganisms that live and mul-
manually or by the mechanical Thran spray gun sampler.
tiply on skin, forming a permanent population.
1.2 A 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 permanently
1.3 In this test method, metric units are used for all
colonize skin.
applications.
1.4 This standard does not purport to address all of the
4. Summary of Test Method
safety concerns, if any, associated with its use. It is the
4.1 Resident Flora:
responsibility of the user of this standard to establish appro-
4.1.1 This test method is conducted on a group of volunteer
priate safety and health practices and determine the applica-
subjects who have refrained from using oral and topical
bility of regulatory limitations prior to use.
antimicrobials for at least one week and exhibit skin flora
1.5 It is the responsibility of the investigator to determine if
3 2
counts of at least 1 3 10 /cm on the target sites.
Good Laboratory Practice (GLP) and Good Clinical Practice
4.1.2 Activity of the antibacterial wash is measured by
(GCP) is required.
comparingbacterialcountsobtainedataspecifiedtimeinterval
2. Referenced Documents after application of the test material to one test site with the
3
activity of a bland soap control or with a baseline value. The
2.1 ASTM Standards:
sitesusedforcomparisonshouldbecontralateraltothetestsite
E 1054 Practices for Evaluating Inactivators of Antimicro-
whenever possible.
bial Agents Used in Disinfectant, Sanitizer, Antiseptic, or
4.2 Transient Organisms (Marker):
Preserved Products
4.2.1 This test method is conducted on a group of volunteer
E 1173 Test Method for Evaluation of a Pre-Operative Skin
subjects who have refrained from using oral and topical
Preparation
antimicrobials for at least one week.
3. Terminology 4.2.2 Activity of the antibacterial wash is measured by
comparing microbial counts of a marker organism applied to
3.1 Definitions of Terms Specific to This Standard:
test sites after application of the test material with counts
obtained after application of a bland soap control to a con-
1
This tests method is under the jurisdiction of ASTM Committee E35 on
tralateral site.
Pesticides and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
5. Significance and Use
Current edition approved April 10, 1997. Published December 1997.
2
Thran spray gun bacterial sampler may be obtained through Dr. Volker Thran,
5.1 The procedure should be used to evaluate test materials
KommissionderEuropaischenGemeinschaften,RuedelaLoi200,B-1049Brussel,
containing antibacterial ingredients that are intended to reduce
Belgium.
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or significantly the number of organisms on intact skin. It also
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
may be used to provide an indication of residual antibacterial
Standards volume information, refer to the standard’s Document Summary page on
activity.
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E1874–97
5.2 Performance of this procedure requires the knowledge 8. Test Control and Baseline Skin Sites
of regulations pertaining to the protection of human subjects
8.1 Select skin sites appropriate for target flora and the test
(see Practices E 1054 and Test Method E 1173).
...