ASTM E2755-22

Standard Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations Using Hands of Adults

SIGNIFICANCE AND USE
5.1 Hand hygiene is considered one of the most important measures for preventing the spread of infectious microorganisms. Hand rubs reduce the microbial load on the hands without the use of soap and water, and are thus an important tool in the practice of good hand hygiene. Alcohol-based hand rubs are recommended in healthcare settings for use on hands that are not visibly soiled. They are formulated to be applied full strength to dry hands, “rubbed in” until dry, and are not rinsed off.  
5.2 This test method is designed specifically to evaluate hand rubs for efficacy in eliminating bacteria from experimentally-contaminated hands. It is designed as an alternative to Test Method E1174, which was intended primarily to evaluate antimicrobial handwashing agents that are lathered with the aid of water and then rinsed off. When using Test Method E1174 to evaluate hand rubs, inadequate drying of the hands after contamination dilutes the test material and can compromise activity, to result in an underestimation of effectiveness. Additionally, because hand rubs are not rinsed after product use, activity can be further degraded by build-up of soil from the contaminating broth and inactivated challenge bacteria on the hands.  
5.2.1 In this method, application to the hands of a small volume of high-titer test bacteria suspension minimizes soil load such that the skin is completely dry prior to application of the test material. Further, by applying the bacterial suspension only prior to those test material application cycles followed by sampling, excessive buildup of killed bacteria on the hands is avoided, and the potential impact of non-volatile test product ingredients on bacteria-eliminating effectiveness after ten consecutive applications can be specifically assessed.  
5.3 A reference control is evaluated for each subject prior to evaluation of the test material. Data from the reference control helps to control for inter-subject variability, inter-experimental variabi...
SCOPE
1.1 This test method is designed to determine the activity of healthcare personnel hand rubs, (also known as hand rubs, hygienic hand rubs, hand sanitizers, or hand antiseptics) against transient microbial skin flora on the hands after a single application and after repeated applications.  
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21 CFR Parts 50 and 56).  
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work with potentially infectious agents at biosafety level 2.2,3  
1.4 Units—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. For more specific precautionary statements, see 8.2.  
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: Published
• Publication Date: 31-Mar-2022
• ICS: 11.080.20 - Disinfectants and antiseptics
• ICS: 71.100.35 - Chemicals for industrial and domestic disinfection purposes
• 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: E2755 − 22
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Healthcare Personnel Hand Rub Formulations Using Hands
1
of Adults
This standard is issued under the fixed designation E2755; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
4
2.1 ASTM Standards:
1.1 Thistestmethodisdesignedtodeterminetheactivityof
E1054PracticesforEvaluationofInactivatorsofAntimicro-
healthcare personnel hand rubs, (also known as hand rubs,
bial Agents
hygienic hand rubs, hand sanitizers, or hand antiseptics)
E1174Test Method for Evaluation of the Effectiveness of
againsttransientmicrobialskinfloraonthehandsafterasingle
Healthcare Personnel Handwash Formulations
application and after repeated applications.
E2276 Test Method for Determining the Bacteria-
1.2 Performance of this procedure requires the knowledge
Eliminating Effectiveness of Hygienic Handwash and
of regulations pertaining to the protection of human subjects
Handrub Agents Using the Fingerpads of Adults
(see 21 CFR Parts 50 and 56).
E2756Terminology Relating toAntimicrobial andAntiviral
Agents
1.3 This test method should be performed by persons with
2.2 Other Standards:
training in microbiology, in facilities designed and equipped
AATCC Test Method 1472004 Antibacterial Activity As-
for work with potentially infectious agents at biosafety level
5
2,3
sessment of Textile Materials: Parallel Streak Method
2.
21 CFR Parts 50 and 56Protection of Human Subjects;
6
1.4 Units—The values stated in SI units are to be regarded
Institutional Review Boards
asstandard.Nootherunitsofmeasurementareincludedinthis
standard.
3. Terminology
1.5 This standard does not purport to address all of the 3.1 Definitions: For definitions of terms used in this
safety concerns, if any, associated with its use. It is the
document, see Terminology E2756.
responsibility of the user of this standard to establish appro-
3.2 Definitions of Terms Specific to This Standard:
priate safety, health, and environmental practices and deter-
3.2.1 healthcare personnel handrub, n—an antimicrobial
mine the applicability of regulatory limitations prior to use.
gel, foam, liquid, spray, or wipe, applied by rubbing to reduce
For more specific precautionary statements, see 8.2.
the transient microbial skin flora on hands that are not visibly
1.6 This international standard was developed in accor-
soiled,andwhichdoesnotrequireapost-treatmentwaterrinse.
dance with internationally recognized principles on standard-
Such agents may also be referred to as hand rubs, hygienic
ization established in the Decision on Principles for the
hand rubs, or hand antiseptics.
Development of International Standards, Guides and Recom-
3.2.2 healthcare personnel handwash, n—a cleanser or
mendations issued by the World Trade Organization Technical
waterless agent intended to reduce transient microbial skin
Barriers to Trade (TBT) Committee.
flora on the hands.
1 4
This test method is under the jurisdiction of ASTM Committee E35 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
responsibility of Subcommittee E35.15 on Antimicrobial Agents. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved April 1, 2022. Published July 2022. Originally the ASTM website.
5
approved in 2010. Last previous edition approved in 2015 as E2755–15. DOI: Available from American Association of Textile Chemists and Colorists
10.1520/E2755–22 (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709, http://
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, 5th ed., www.aatcc.org.
6
U.S. Department of Health and Human Services, U.S. Government Printing Office, AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Washington, DC, 2007. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
3
45 CFR Part 46 Protection of Human Subjects (Effective July 19, 2018). www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2755 − 22
3.2.3 test bacteria, n—an applied inoculum of bacteria that Method E1174 to evaluate hand rubs, inadequate dr
...

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: E2755 − 15 E2755 − 22
Standard Test Method for
Determining the Bacteria-Eliminating Effectiveness of
Healthcare Personnel Hand Rub Formulations Using Hands
1
of Adults
This standard is issued under the fixed designation E2755; 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 determine the activity of healthcare personnel hand rubs, (also known as hand rubs, hygienic
hand rubs, hand sanitizers, or hand antiseptics) against transient microbial skin flora on the hands after a single application and
after repeated applications.
1.2 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (see 21
CFR Parts 50 and 56).
1.3 This test method should be performed by persons with training in microbiology, in facilities designed and equipped for work
2,3
with potentially infectious agents at biosafety level 2.
1.4 Units—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. For more specific precautionary statements, see 8.2.
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. For more specific precautionary statements, see 8.2.
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.
1
This test 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 May 15, 2015April 1, 2022. Published June 2015July 2022. Originally approved in 2010. Last previous edition approved in 20102015 as
E2755–10.–15. DOI: 10.1520/E2755–1510.1520/E2755–22
2
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, 5th ed., U.S. Department of Health and Human Services, U.S. Government Printing Office,
Washington, DC, 2007.
3
45 CFR Part 46 Protection of Human Subjects (Effective July 19, 2018).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E2755 − 22
2. Referenced Documents
4
2.1 ASTM Standards:
E1054 Practices for Evaluation of Inactivators of Antimicrobial Agents
E1174 Test Method for Evaluation of the Effectiveness of Healthcare Personnel Handwash Formulations
E2276 Test Method for Determining the Bacteria-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using
the Fingerpads of Adults
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
2.2 Other Standards:
5
AATCC Test Method 147 2004 Antibacterial Activity Assessment of Textile Materials: Parallel Streak Method
6
21 CFR Parts 50 and 56 Protection of Human Subjects; Institutional Review Boards
3. Terminology
3.1 Definitions: For definitions of terms used in this document, see Terminology E2756.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 healthcare personnel handrub, n—an antimicrobial gel, foam, liquid, spray, or wipe, applied by rubbing to reduce the
transient microbial skin flora on hands that are not visibly soiled, and which does not require a post-treatment water rinse. Such
agents may also be referred to as hand rubs, hygienic hand rubs, or hand antiseptics.
3.2.2 healthcare personnel handwash, n—a cleanser or waterless agent intended to reduce transient microbial skin flora on the
hands.
3.2.3 test bacteria, n—an applied inoculum of bacteria that has characteristics which allow it to be readily ident
...