ASTM E1883-02(2015)

Standard Test Method for Assessment of an Antibacterial Handwash Product by Multiple Basin Wash Technique

SIGNIFICANCE AND USE
5.1 This procedure should be used for in vivo evaluation of the performance of antibacterial handwash products that are intended to reduce the skin micro flora following repeated use. Activity against the combined transient and resident micro flora may be assessed. Historically counts from the first basin are considered to be transients.4 ,6 The latter measurement is probably more meaningful as the resident population is more stable.  
5.1.1 This test method is applicable for testing all forms of topical antimicrobial handwash formulations.
SCOPE
1.1 This test method covers determining the effectiveness of an antibacterial handwash for reducing the level of aerobic bacterial flora on the hands, following an extended period of use.  
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 distance. In this case, inches are used and metric units follow in parentheses.  
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects. (Title 21 CFR, Part 50).  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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: Published
• Publication Date: 30-Sep-2015
• 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.
Designation: E1883 − 02 (Reapproved 2015)
Standard Test Method for
Assessment of an Antibacterial Handwash Product by
1
Multiple Basin Wash Technique
This standard is issued under the fixed designation E1883; 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 cation & Part 56, Institutional Review Boards
1.1 This test method covers determining the effectiveness of
3. Terminology
an antibacterial handwash for reducing the level of aerobic
3.1 Definitions:
bacterial flora on the hands, following an extended period of
3.1.1 active ingredient—a substance performing a function
use.
defined by this method.
1.2 A knowledge of microbiological techniques is required
3.1.2 active test formulation—a formulation with an active
for these procedures.
ingredient.
1.3 In this test method metric units are used for all
3.1.3 control test formulation—a formulation without an
applications, except for distance. In this case, inches are used
active in this test method. Frequently a bland soap.
and metric units follow in parentheses.
3.1.4 neutralization—a process that results in quenching or
1.4 Performance of this procedure requires the knowledge
inactivation of the antimicrobial activity of a formulation. This
of regulations pertaining to the protection of human subjects.
may be achieved with dilution of the formulation or with the
(Title 21 CFR, Part 50).
use of chemical agents, called neutralizers.
1.5 The values stated in SI units are to be regarded as
3.1.5 neutralizer—a procedure or chemical agent used to
standard. No other units of measurement are included in this
inactivate,neutralize,orquenchthemicrobiocidalpropertiesof
standard.
an antimicrobial agent.
1.6 This standard does not purport to address all of the
3.1.6 resident microorganisms—microorganisms that live
safety concerns, if any, associated with its use. It is the
and multiply on skin, forming a permanent population.
responsibility of the user of this standard to establish appro-
3.1.7 test formulation—a formulation containing an active
priate safety and health practices and determine the applica-
ingredient.
bility of regulatory limitations prior to use.
3.1.8 transient microorganisms—microorganisms that con-
2. Referenced Documents
taminate but do not normally permanently colonize skin.
2
2.1 ASTM Standards:
4. Summary of Test Method
D1193 Specification for Reagent Water
E1054 Test Methods for Evaluation of Inactivators of Anti-
4.1 This hand degerming protocol is a modification of the
microbial Agents
Cade Handwashing Procedure, that is a serial basin hand wash
3
4,5
2.2 Other Standard:
sampling technique.
Title 21 Code of Federal Regulations (CFR), Part 50
4.1.1 Two baseline bacterial counts will be determined for
Protection of Human Subjects: Informed Consent Verifi-
thehandsandapost-usagecountwillbedoneaftertwelvedays
of antibacterial handwash usage. The samples are collected
1 frombasinwashwaterfollowingoneormore60-swasheswith
This test method is under the jurisdiction of ASTM Committee E35 on
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
a bar soap that does not contain an antimicrobial. At each
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
sampling interval samples may be collected from the first and
Current edition approved Oct. 1, 2015. Published November 2015. Originally
or fifth hand wash in a series of five washes.
approved in 1997. Last previous edition approved in 2007 as E1883 – 02(2007).
DOI: 10.1520/E1883-02R15.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Cade, A.R., “A Method for Testing Degerming Efficacy of Hexachlorophene
Standards volume information, refer to the standard’s Document Summary page on Soaps,” Journal of the Society of Cosmetic Chemistry, Vol. 2: 1951, pp 181–291.
5
the ASTM website. Price, P.B., “The bacteriology of normal skin: a new quantitative test applied to
3
Available from U.S. Government Publishing Office, 732 N. Capitol St., NW, a study of the bacterial flora and disinfectant action of mechanical cleansing,”
Washington, DC 20401-0001, http://www.gpo.gov. Journal Infection Control, Vol. 63:1938, pp 301–318.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1883 − 02 (2015)
4.1.2 T
...