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ASTM E3058-16

(Test Method)

Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations

Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations

SIGNIFICANCE AND USE
5.1 Many marketed hand antiseptics make claims of "long-lasting protection” or “extended kill” (for example 6 hours), which are typically based on results of testing as described in Test Method E1882 or Guide E2752, or both. At this time there are no standard methods for evaluating a hand antiseptic formulation for its ability to kill microorganisms on hands when a “dry” contamination event occurs at some time after product use. This test method provides a method to substantiate residual kill claims for hand antiseptics.
SCOPE
1.1 This test method is designed to determine the residual killing activity of skin antiseptics against transient microbial skin flora on the hands .2 It may be used to evaluate products that are used with the aid of water and rinsed off and those that are used without the aid of water and not rinsed off.  
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.  
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 8.1.

General Information

Status
Published
Publication Date
14-Nov-2016
ICS
11.080.20 - Disinfectants and antiseptics
Technical Committee
E35 - Pesticides, Antimicrobials, and Alternative Control Agents
Drafting Committee
E35.15 - Antimicrobial Agents
Current Stage
Ref Project

Relations

Refers
ASTM E2752-10(2015) - Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products
Effective Date
01-Oct-2015
Refers
ASTM E2197-17 - Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
Effective Date
01-Dec-2017
Refers
ASTM E2197-17e1 - Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
Effective Date
01-Dec-2017
Refers
ASTM E2756-18 - Standard Terminology Relating to Antimicrobial and Antiviral Agents
Effective Date
01-Apr-2018
Refers
ASTM E2756-19 - Standard Terminology Relating to Antimicrobial and Antiviral Agents
Effective Date
01-Nov-2019

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ASTM E3058-16 - Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic FormulationsASTM E3058-16 - Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
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ASTM E3058-16 - Standard Test Method for Determining the Residual Kill Activity of Hand Antiseptic Formulations
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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: E3058 − 16
Standard Test Method for
Determining the Residual Kill Activity of Hand Antiseptic
1
Formulations
This standard is issued under the fixed designation E3058; 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 E2197Quantitative Disk Carrier Test Method for Determin-
ing Bactericidal, Virucidal, Fungicidal, Mycobactericidal,
1.1 This test method is designed to determine the residual
and Sporicidal Activities of Chemicals
killing activity of skin antiseptics against transient microbial
2 E2756Terminology Relating toAntimicrobial andAntiviral
skin flora on the hands . It may be used to evaluate products
Agents
thatareusedwiththeaidofwaterandrinsedoffandthosethat
4
2.2 Federal Standards:
are used without the aid of water and not rinsed off.
21 CFR Part 50Protection of Human Subjects
1.2 Performance of this procedure requires the knowledge
21 CFR Part 56Institutional Review Boards
of regulations pertaining to the protection of human subjects
(see 21 CFR Parts 50 and 56).
3. Terminology
1.3 This test method should be performed by persons with
3.1 Definitions—For definitions of terms used in this
training in microbiology, in facilities designed and equipped
document, see Terminology E2756.
for work with potentially infectious agents at biosafety level 2.
3.2 Definitions of Terms Specific to This Standard:
1.4 Units—The values stated in SI units are to be regarded
3.2.1 healthcare personnel hand rub, n—an antimicrobial
asstandard.Nootherunitsofmeasurementareincludedinthis
gel, foam, liquid, spray, or wipe, applied by rubbing to reduce
standard.
the transient microbial skin flora on hands that are not visibly
soiled,andwhichdoesnotrequireapost-treatmentwaterrinse.
1.5 This standard does not purport to address all of the
Such agents may also be referred to as hand rubs, hygienic
safety concerns, if any, associated with its use. It is the
hand rubs, hand sanitizers, or hand antiseptics.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3.2.2 healthcare personnel hand wash, n—acleanserrequir-
bility of regulatory limitations prior to use. For more specific
ing rinsing or a non-rinse agent intended to reduce transient
precautionary statements see 8.1.
microbial skin flora on the hands.
3.2.3 room temperature, n—temperature in the range of 20
2. Referenced Documents
to 25°C (68 to 77°F).
3
2.1 ASTM Standards:
3.2.4 test bacteria, n—an applied suspension of bacteria
E1054Test Methods for Evaluation of Inactivators of Anti-
having characteristics that permit ready identification of colo-
microbial Agents
nies. Test bacteria are used to simulate a transient topical
E2752Guide for Evaluation of Residual Effectiveness of
microbial contaminant. These may also be referred to as test
Antibacterial Personal Cleansing Products
organisms, marker organisms, simulants, or contaminants.
E1882Test Method for Evaluation ofAntimicrobial Formu-
3.2.5 test material, n—a product or formulation that incor-
lations by the Agar Patch Technique
porates an antimicrobial ingredient(s).
1
This test method is under the jurisdiction of ASTM Committee E35 on
4. Summary of Test Method
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
4.1 This test method uses adult subjects who have provided
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
Current edition approved Nov. 15, 2016. Published December 2016. DOI:
a written informed consent and whose hands have been
10.1520/E3058–16
determined to be free from any clinical evidence of skin
2
Rutter J.D., Angiulo K., Macinga D.R., Measuring residual activity of topical
disorders, dermatosis, cuts, lesions, or hangnails at the time of
antimicrobials: is the residual activity of chlorhexidine an artefact of laboratory
methods?J. Hosp. Infect. 88:113-115, 2014
3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Available from U.S. Government Printing Office, Superintendent of
Standards volume information, refer to the standard’s Document Summary page on Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, 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

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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.  
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Standard Practice for Evaluating Static and Cidal Chemical Decontaminants against Bacillus Spores using Centrifugal Filtration Tubes

SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be small enough to fit inside filter units mentioned in 4.1.  
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, and safe, while minimizing labor and addressing statistical confidence (1, 2).  
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that all the spores were accounted for.  
5.2.2 Statistical Confidence—The use of five independent preparations of spore inocula for a statistical n of 5.  
5.2.3 Sensitivity—Allows for complete detection of all culturable spores inoculated on a coupon, including the spores that remain attached to the coupon.
5.2.3.1 The limit of detection is dependent on the culturability of fully matured spores to germinate, outgrow and divide in the presence of the extraction medium (1% tryptic soy broth, 100 mM L-Alanine, 1 mM inosine, 0.05% Tween 80) and/or on tryptic soy agar.
5.2.3.2 Results presented in Refs (1, 3) (and currently unpublished results) indicate that these media, combined with the test temperatures and conditions described herein will generate results with a high level of practical confidence for detecting culturable Bacillus spores.  
5.2.4 Safety—Inoculated coupons are contained within filter units.  
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same filter unit to minimize coupon handling steps.  
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1, 2).  
5.2.7 Wide application for numerous Bacillus species and strains. The method has also been modified and used for vegetative bacteria and viruses as well (1, 2).
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1.1 This practice is used to quantify the efficacy of liquid or solid decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials. This practice can distinguish between bactericidal and bacteriostatic chemicals within decontamination mixtures. This is important because many decontaminants contain both reactive compounds and high concentrations of bacteriostatic surfactants. All test samples are directly compared to pre-neutralized controls, un-inoculated negative growth controls, and solution controls on the same day as the test in order to increase practical confidence in the inactivation data.  
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SIGNIFICANCE AND USE
5.1 The practice can be used to evaluate coupon materials of any composition, insofar as the coupon can be prepared small enough to fit inside a 50-ml conical tube.  
5.2 This practice defines procedures that are quantitative, scalable, rapid, sensitive, safe, reduces consumables, minimizes labor and addresses statistical confidence (1, 2, 4).  
5.2.1 Quantitative—The total number of spores per coupon is determined by dilution-plating, and all spores remaining on the coupon are assayed for activity in the extraction tube to provide confidence that 100 % of spores were assayed.  
5.2.2 Statistical Confidence—The use of five independent preparations of spore inoculum for a statistical N of 5.  
5.2.3 Sensitivity—Allows for complete detection of all viable spores inoculated on a coupon, including the spores that remain attached to the coupon.  
5.2.4 Safety—Inoculated coupons are contained within 0.2 µm filter-capped 50-ml conical tubes. The 0.2 µm filter allows vaporous decontaminants to pass through while preventing escape of spores, thereby providing an important level of containment when working with pathogenic strains.  
5.2.5 Simplicity of Testing—Tests and extractions are performed in the same 50-ml conical tube to minimize handling steps.  
5.2.6 Scalable and Rapid—A maximum of 36 samples can be processed in 1 h by two technicians; a total of 300 samples have been processed by six technicians in 5 h (1-3).  
5.2.7 Wide application for numerous Bacillus species and strains.
Note 1: This practice differs from similar quantitative methods (E2111, E2197 and E2414) in the size and variety of coupon materials available for testing, in the practical confidence of the statistics, the application of the decontaminant, scalability and sensitivity.
SCOPE
1.1 This practice is used to quantify the efficacy of vaporous decontaminants on Bacillus spores dried on the surface of coupons made from porous and non-porous materials and contained within 0.2µm filter-capped tubes.  
1.2 This practice should be performed only by those trained in microbiological techniques, are familiar with antimicrobial (sporicidal) agents and with the end use of such products.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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1.5 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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Standard Test Method for Evaluation of Surgical Hand Scrub Formulations

SIGNIFICANCE AND USE
5.1 The procedure in this test method should be used to evaluate the activity of the test formulation in reducing the bacterial population of the hands immediately after a single use and to determine persistent activity (inhibition of growth) after 6 h. Optionally, measurements of persistent activity after a 3 h period and measurements of cumulative activity may be made after repetitive uses over a five day period.
SCOPE
1.1 This test method is designed to measure the reduction of microbial flora on the skin. It is intended for determining both immediate and persistent (continuing antimicrobial effect) microbial reductions, after single or repetitive treatments, or both. It may also be used to measure cumulative antimicrobial activity after repetitive treatments.  
1.2 A knowledge of microbiological techniques is required for these procedures.  
1.3 Performance of this procedure requires the knowledge of regulations pertaining to the protection of human subjects (21 CFR, Parts 50 and 56)  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4.1 In this test method, SI units are used for all applications, except for distance, in which case inches are used and SI units follow in parentheses.  
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.  
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.

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