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ASTM E1838-96

(Test Method)

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers

SCOPE
1.1 Human skin does not carry viruses as a part of its resident flora. Hands transiently contaminated with viruses, however, can act as vehicles for the spread of many types of viral infections. Hygienic hand washing is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reduction in the virus load may be due to a combination of virus inactivation and removal of infectious virus from the skin.  
1.2 Standard test methods to assessthe capacity of hygienic handwash agents to reduce virus levels on hands are not presently available. This test method, therefore, has been designed to determine the comparative virus-eliminating effectiveness of germicidal or non-germicidal hygienic handwash agents. This test method is not meant for use with surgical hand scrubs or preoperative skin preps.  
Note 1- The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2.  
1.3 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
09-Oct-1996
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Replaced By
ASTM E1838-02 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers
Effective Date
10-Apr-2002

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ASTM E1838-96 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult VolunteersASTM E1838-96 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers
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ASTM E1838-96 - Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash Agents Using the Fingerpads of Adult Volunteers
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Standards Content (Sample)

Designation: E 1838 – 96
Standard Test Method for
Determining the Virus-Eliminating Effectiveness of Liquid
Hygienic Handwash Agents Using the Fingerpads of Adult
1
Volunteers
This standard is issued under the fixed designation E 1838; 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.
INTRODUCTION
Hands play an important role in the spread of many viral infections, thus proper and regular
handwashing is considered crucial in preventing the spread of viral infections, particularly in
health-care settings, day-care centers, and food-handling establishments. Many viruses that are known
to spread through contaminated hands can remain infectious for several hours on human hands, and
also may be more resistant than the bacteria commonly used to evaluate the germicidal activity of
2
handwash agents (1,2). Contaminated hands also can readily transfer infectious virus to other surfaces
(1,2). Hand antisepsis has been shown to interrupt the spread of viral infections (3). Standardized
methods to assess the virus-eliminating potential of handwash agents have not been available and this
test method addresses this gap.
1. Scope 2. Referenced Documents
1.1 Human skin does not carry viruses as a part of its 2.1 ASTM Standards:
3
resident flora. Hands transiently contaminated with viruses, D 1129 Terminology Relating to Water
however, can act as vehicles for the spread of many types of E 1115 Test Method for Evaluation of Surgical Hand Scrub
4
viral infections. Hygienic hand washing is meant to reduce the Formulation
load of viruses and other transient microorganisms on hands, E 1173 Test Method for Evaluation of a Pre-Operative Skin
4
thereby reducing the risk of disease transmission. Such reduc- Preparation
tion in the virus load may be due to a combination of virus E 1174 Test Method for Evaluation of Health Care Person-
4
inactivation and removal of infectious virus from the skin. nel Handwash Formulation
1.2 Standard test methods to assess the capacity of hygienic
3. Terminology
handwash agents to reduce virus levels on hands are not
presently available. This test method, therefore, has been 3.1 Definitions—For definitions of general terms used in
this test method, refer to Terminology D 1129.
designed to determine the comparative virus-eliminating effec-
tiveness of germicidal or non-germicidal hygienic handwash 3.2 Definitions of Terms Specific to This Standard:
3.2.1 hygienic (health-care personnel) handwash agents,
agents. This test method is not meant for use with surgical hand
scrubs or preoperative skin preps. n—agents generally used for handwashing by personnel in
hospitals, other health-care facilities, day-care centers, nursing
NOTE 1—The test method should be performed by persons with training
homes, and food-handling establishments should be safe for
in virology in facilities designed and equipped for work with infectious
repeated use, nonirritating, fast-acting, and efficient in elimi-
agents at biosafety level 2 (4).
nating transient microorganisms from intact skin.
1.3 This standard does not purport to address all of the
3.2.2 nonmedicated soap, n—a soap or detergent that is
safety concerns, if any, associated with its use. It is the
mild to the skin and does not contain any germicidal chemicals.
responsibility of the user of this standard to establish appro-
3.2.3 virus-eliminating (removing) agent, n—any agent that
priate safety and health practices and determine the applica-
rids hands of viruses by either killing them on the skin or by
bility of regulatory limitations prior to use.
dislodging them for subsequent wash-off.
3.2.4 virus inactivating agent, n—any agent that renders a
1
virus noninfectious.
This test method is under the jurisdiction of ASTM Committee E-35 on
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antibacterial
Agents.
Current edition approved Oct. 10, 1996. Published December 1996.
2 3
The boldface numbers in parentheses refer to the list of references at the end of Annual Book of ASTM Standards, Vol 11.04.
4
this standard. Annual Book of ASTM Standards, Vol 11.05.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E 1838
4. Summary of Test Method 6. Equipment and Apparatus
6.1 Laminar Flow Cabinet—A Class II biological safety
4.1 This test method is conducted on a group of adult
volunteers who have provided informed consent and the skin of cabinet is required for virus work. The procedures for the
whose hands has been determined to be free from any apparent proper maintenance and use of such cabinets are given in Ref
damage. Panelists are to refrain from any products containing (4).
antimicrobial agents for one week
...

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