ASTM E2870-19
(Practice)Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
SIGNIFICANCE AND USE
5.1 Hand hygiene is important for preventing the spread of many types of infections.
5.2 During routine activities, it is primarily the palmar surface, comprising palms, fingers, and finger pads, of the hands that may become contaminated with transient microorganisms. The contamination could then be transferred to articles touched or handled or to other parts of the body. Palmar contamination is used in Test Method E2784.
5.3 In Test Method E1174, incomplete drying of the experimentally contaminated hands dilutes the applied test product, thus compromising its activity. Application of a smaller volume of the microbial test suspension keeps the soil load to a reasonable level while allowing the hands to become visibly dry prior to application of the test material and reference formulation. These modifications are aimed at producing a better approximation of in-use conditions and a more realistic assessment of the test substance, thus providing a more reliable indication of product performance.
5.4 Unlike Test Methods E1174, E2755, and E2784, this practice enables a direct comparison between two formulations on the same subject. The practice also uses a mechanical scrubbing machine in conjunction with the glove juice technique for more efficient recovery of viable test bacteria from the palms. The mechanical sampling results in greater recovery of bacteria from the palms than conventional recovery methods, such as massaging.
SCOPE
1.1 This practice covers and is designed to determine the relative effectiveness of antimicrobial handwashing agents in reducing transient microorganisms using a controlled handwash.
1.2 Knowledge of microbiological techniques is required for these procedures.
1.3 This practice is used to evaluate topical antimicrobial handwashing formulations.
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR Parts 50 and 56).
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. For more specific precautionary statements, see 8.1.
1.7 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.
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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: E2870 − 19
Standard Practice for
Evaluating Relative Effectiveness of Antimicrobial
Handwashing Formulations using the Palmar Surface and
1
Mechanical Hand Sampling
This standard is issued under the fixed designation E2870; 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 E1054Test Methods for Evaluation of Inactivators of Anti-
microbial Agents
1.1 This practice covers and is designed to determine the
E1174Test Method for Evaluation of the Effectiveness of
relative effectiveness of antimicrobial handwashing agents in
Health Care Personnel Handwash Formulations
reducing transient microorganisms using a controlled hand-
E2755 Test Method for Determining the Bacteria-
wash.
Eliminating Effectiveness of Healthcare Personnel Hand
1.2 Knowledge of microbiological techniques is required
Rub Formulations Using Hands of Adults
for these procedures.
E2756Terminology Relating toAntimicrobial andAntiviral
1.3 This practice is used to evaluate topical antimicrobial Agents
E2784Test Method for Evaluation of the Effectiveness of
handwashing formulations.
Handwash Formulations Using the Paper Towel (Palmar)
1.4 Performance of this procedure requires the knowledge
Method of Hand Contamination
of regulations pertaining to the protection of human subjects
2.2 Other Standards:
(21 CFR Parts 50 and 56).
AATCC Test Method 147Antibacterial Assessment of Tex-
3
1.5 The values stated in SI units are to be regarded as
tile Materials: Parallel Streak Method
4
standard. No other units of measurement are included in this
21 CFR Part 50 Protection of Human Subjects
4
standard.
21 CFR Part 56Institutional Review Boards
1.6 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1 Definitions—For definitions of terms used in this
priate safety, health, and environmental practices and deter-
document, see Terminology E2756.
mine the applicability of regulatory limitations prior to use.
3.2 Definitions of Terms Specific to This Standard:
For more specific precautionary statements, see 8.1.
3.2.1 active ingredient, n—a substance added to a formula-
1.7 This international standard was developed in accor-
tion specifically for the inhibition or inactivation of microor-
dance with internationally recognized principles on standard-
ganisms.
ization established in the Decision on Principles for the
3.2.2 reference formulation, n—formulation against which
Development of International Standards, Guides and Recom-
the activity of the test formulation is compared, for example, a
mendations issued by the World Trade Organization Technical
handwash without an active ingredient or a handwash with a
Barriers to Trade (TBT) Committee.
different active ingredient than the test formulation. This
2. Referenced Documents formulation is not considered a standard.
2
3.2.3 test material, n—a product or formulation which
2.1 ASTM Standards:
incorporates antimicrobial ingredients(s).
3.2.4 test organism, n—anappliedinoculumofanorganism
1
This practice is under the jurisdiction ofASTM Committee E35 on Pesticides,
Antimicrobials, and Alternative Control Agents and is the direct responsibility of that has characteristics which allow it to be readily identified.
Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved April 1, 2019. Published May 2019. Originally
3
approved 2013. Last previous edition approved 2013 as E2870–13. DOI: 10.1520/ Available from American Association of Textile Chemists and Colorists
E2870-19. (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709, http://
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or www.aatcc.org.
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
the ASTM website. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2870 − 19
The test organism is used to simulate a transient topical ganisms. The contamination could then be transferred to
microbial contaminant. It may also be referred to as
...
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: E2870 − 13 E2870 − 19
Standard Test Method Practice for
Evaluating Relative Effectiveness of Antimicrobial
Handwashing Formulations using the Palmar Surface and
1
Mechanical Hand Sampling
This standard is issued under the fixed designation E2870; 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 covers and is designed to determine the relative effectiveness of antimicrobial handwashing agents in
reducing transient microorganisms using a controlled handwash.
1.2 Knowledge of microbiological techniques is required for these procedures.
1.3 This test method is used to evaluate topical antimicrobial handwashing formulations.
1.4 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR
Parts 50 and 56).
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. For more specific precautionary statements, see 8.1.
2. Referenced Documents
2
2.1 ASTM Standards:
E1054 Test Methods for Evaluation of Inactivators of Antimicrobial Agents
E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations
E2755 Test Method for Determining the Bacteria-Eliminating Effectiveness of Healthcare Personnel Hand Rub Formulations
Using Hands of Adults
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
E2784 Test Method for Evaluation of the Effectiveness of Handwash Formulations Using the Paper Towel (Palmar) Method of
Hand Contamination
2.2 Other Standards:
3
AATCC Test Method 147 Antibacterial Assessment of Textile Materials: Parallel Streak Method
4
21 CFR Part 50 Protection of Human Subjects
4
21 CFR Part 56 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 active ingredient, n—a substance added to a formulation specifically for the inhibition or inactivation of microorganisms.
1
This test method practice 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 April 1, 2013April 1, 2019. Published May 2013May 2019. Originally approved 2013. Last previous edition approved 2013 as E2870–13. DOI:
10.1520/E2870-13.10.1520/E2870-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Association of Textile Chemists and Colorists (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709, http://www.aatcc.org.
4
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E2870 − 19
3.2.2 reference formulation, n—formulation against which the activity of the test formulation is compared, for example, a
handwash without an active ingredient or a handwash with a different active ingredient than the test formulation. This formulation
is not considered a standard.
3.2.3 test material, n—a product or formulation which incorporates antimicrobial ingredients(s).
3.2.4 test organism, n—an applied inoculum of an organism that has characteristics which allow it to be readily identified. The
test organism is used to simulate a transient topical microbial contaminant. It may also be referred to as a marker organism,
bacterial simulant, or bacterial contaminant.
4. Summary of Test Method
4.1 This test method uses adult subjects who have provided a written informed consent and whose hand
...
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