ASTM E2756-19

Standard Terminology Relating to Antimicrobial and Antiviral Agents

SCOPE
1.1 The purpose of this terminology standard is to establish uniformity in terms used in the field of antimicrobial and antiviral agent testing. Terms are adapted from related fields such as regulatory terms defined by law and definitions as supported by test requirements.  
1.2 The terms are appropriate to the wide range of interest related to standards developed in the area of antimicrobial and antiviral testing.  
1.3 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-Oct-2019
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaces: ASTM E2756-18 - Standard Terminology Relating to Antimicrobial and Antiviral Agents
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3011-22 - Standard Practice for In vitro production of <emph type="ital">Clostridioides difficile</emph > Spores
• Effective Date: 01-Nov-2019
• Referred By: ASTM E2870-19 - Standard Practice for Evaluating Relative Effectiveness of Antimicrobial Handwashing Formulations using the Palmar Surface and Mechanical Hand Sampling
• Effective Date: 01-Nov-2019
• Referred By: ASTM E1589-21 - Standard Practice for Evaluation of First Aid Antiseptic Drug Products
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3218-21 - Standard Test Method for Quantitative Method for Testing Antimicrobial Agents against Spores of <emph type="ital">C. difficile</emph> on Hard, Nonporous Surfaces
• Effective Date: 01-Nov-2019
• Referred By: ASTM E2111-12(2018) - Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemicals
• Effective Date: 01-Nov-2019
• Referred By: ASTM E2471-23 - Standard Test Method for Using Seeded-Agar for the Screening Assessment of Antimicrobial Activity In Carpets
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3371-22 - Standard Test Method for Measuring the Ability of a Synthetic Polymeric Material to Resist Bacterial Adherence
• Effective Date: 01-Nov-2019
• Referred By: ASTM D8506-23 - Standard Guide for Microbial Contamination and Biodeterioration in Turbine Oils and Turbine Oil Systems
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3031-20 - Standard Practice for Determination of Antibacterial Activity on Ceramic Surfaces
• Effective Date: 01-Nov-2019
• Referred By: ASTM E1482-23 - Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3151-18 - Standard Test Method for Determining Antimicrobial Activity and Biofilm Resistance Properties of Tube, Yarn, or Fiber Specimens
• Effective Date: 01-Nov-2019
• Referred By: ASTM E1428-15a - Standard Test Method for Evaluating the Performance of Antimicrobials in or on Polymeric Solids Against Staining by <i>Streptomyce species </i> (A Pink Stain Organism) (Withdrawn 2024)
• Effective Date: 01-Nov-2019
• Referred By: ASTM E1052-20 - Standard Practice to Assess the Activity of Microbicides against Viruses in Suspension
• Effective Date: 01-Nov-2019
• Referred By: ASTM E3226-19 - Standard Test Method for Processing Cellulose Sponge-wipes to Detect <emph type="ital" >Bacillus anthracis</emph> Spores Sampled from Environmental Surfaces
• Effective Date: 01-Nov-2019

Overview

ASTM E2756-19: Standard Terminology Relating to Antimicrobial and Antiviral Agents establishes a uniform set of definitions for terms widely used in the testing and application of antimicrobial and antiviral agents. Developed by ASTM International, this terminology standard ensures consistency and clarity in communications across regulatory, laboratory, and industry environments involved in the assessment and implementation of antimicrobial and antiviral agent technologies.

The standard draws from both regulatory language and test-specific definitions, making it relevant to professionals engaged in developing, testing, and regulating products such as disinfectants, sanitizers, preservatives, and antiseptics. By employing internationally recognized standardization principles, ASTM E2756-19 supports harmonized practices essential to global trade, regulatory compliance, and technical development in the antimicrobial and antiviral sectors.

Key Topics

• Comprehensive Terminology: Definitions include key concepts such as accuracy, bias, efficacy, effectiveness, antimicrobial, antiviral, antiseptic, disinfectant, sterility, biofilm, carrier, inoculum, and surrogate microorganism.
• Scope of Terms: Terms span chemical, physical, and procedural aspects of antimicrobial and antiviral agent testing, addressing various application environments, including healthcare, industry, and consumer goods.
• Application of Terms: The terminology supports methods for microbial inactivation, control, quantification, and resistance measurement, such as minimum inhibitory concentration (MIC), D-value, and concepts like persistent effect or cumulative effect.
• Alignment with International Principles: Developed per World Trade Organization TBT Committee guidelines, the standard promotes international compatibility and facilitates global regulatory acceptance.

Applications

ASTM E2756-19 terminology is critically important in the following scenarios:

• Regulatory Submissions and Compliance: Ensures clear, standardized language when submitting product registrations for disinfectants, sanitizers, and antiviral agents to authorities and when interpreting regulatory texts.
• Laboratory Testing and Protocols: Provides a consistent vocabulary for designing, conducting, and reporting microbiological efficacy studies, including tests for surface disinfectants, hand hygiene products, and preservatives.
• Product Development and Quality Assurance: Assists manufacturers in framing test objectives, product claims, and performance metrics using accepted terminology. This clarity enhances cross-lab reproducibility and data interpretation.
• Training and Education: Serves as a reference for training laboratory personnel, regulatory affairs specialists, and quality professionals, reducing ambiguity in technical communication.
• Cross-Disciplinary Communication: Facilitates effective dialogue between chemists, biologists, engineers, and regulatory bodies by eliminating uncertainty in key terms.

Related Standards

ASTM E2756-19 is closely linked to a wide array of ASTM standards addressing various aspects of antimicrobial and antiviral agent efficacy, safety, and testing methodologies. Notable related standards include:

• ASTM E640: Test Method for Preservatives in Water-Containing Cosmetics
• ASTM E645: Practice for Evaluating Microbicides in Cooling Water Systems
• ASTM E1052 & E1053: Test Methods for Assessing Virucidal Activity
• ASTM E1115 & E1173: Methods for Surgical Hand Scrubs and Skin Preparations
• ASTM E2315: Guide for Time-Kill Assessment of Antimicrobial Activity
• ASTM E3135: Practice for Evaluating Ultraviolet Germicidal Irradiation Efficacy

For a comprehensive list, consult the ASTM online standards database or the bibliography within ASTM E2756-19.

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Keywords: ASTM E2756-19, antimicrobial, antiviral agents, terminology standard, disinfectant, sanitizer, efficacy testing, microbiological methods, international standardization, regulatory compliance, biofilm, laboratory test methods, product development.

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: E2756 − 19
Standard Terminology Relating to
Antimicrobial and Antiviral Agents
This standard is issued under the fixed designation E2756; 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.
DISCUSSION—A statement of bias is not possible because standard
1. Scope
reference materials are not available for most microbiological methods.
1.1 The purpose of this terminology standard is to establish
uniformity in terms used in the field of antimicrobial and biofilm, n—microorganisms living in a self-organized commu-
antiviral agent testing. Terms are adapted from related fields nityattachedtosurfaces,interfaces,oreachother,embedded
such as regulatory terms defined by law and definitions as in a matrix of extracellular polymeric substances of micro-
supported by test requirements. bial origin, while exhibiting altered phenotypes with respect
to growth rate and gene transcription.
1.2 The terms are appropriate to the wide range of interest
related to standards developed in the area of antimicrobial and
biofouling, n—the unwanted accumulation of organisms
antiviral testing.
and/or their products on surfaces.
1.3 This international standard was developed in accor-
cleaner-sanitizer, n—a physical or chemical agent that re-
dance with internationally recognized principles on standard-
moves soil from an object and reduces numbers of microor-
ization established in the Decision on Principles for the
ganisms on non-food contact surfaces.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
carrier, n—a surrogate surface or matrix that facilitates the
Barriers to Trade (TBT) Committee.
interaction of test microorganisms and treatment(s).
cell monolayer, n—a single layer of eukaryotic cells typically
2. Terminology
propogated on a glass or plastic surface to which they are
GENERAL ANTIMICROBIAL AND ANTIVIRAL
securely attached.
TERMS
cleansing wash, n—a procedure intended to remove soil or
accuracy, n—a measure of the degree of conformity of a value
residue.
generatedbyaspecificproceduretotheassumedoraccepted
clastogen, n—an agent that reduces chromosomal breakage.
true value, and includes both precision and bias.
composite sample, n—a series of grab samples integrated into
ambient temperature, n—temperature of the environment in
a single sample or samples collected at specific times and
which a test method is performed.
integrated into a single sample.
antibacterial, adj—describes an agent that kills bacteria or
cooling system, n—equipment and coolant used for the re-
suppresses their growth or reproduction.
moval of heat from processes, equipment, or both.
antimicrobial, adj—describes an agent that kills or inactivates
microorganisms or suppresses their growth or reproduction. cooling water, n—any water-based solution that absorbs and
transfers heat in a heat exchange system.
antiseptic, n—a material for use on living tissue that either
destroys microorganisms or suppresses their growth. cumulative effect, n—a progressively additive reduction in the
numbers of viable microorganisms measured from an estab-
bias, n—a systematic error that contributes to the difference
lished baseline following repeated applications of a material
between the mean of a large number of test results and an
or procedure.
accepted reference value (ASTM Form and Style Manual).
decontaminant, n—a physical or chemical agent or process
that destroys pathogenic or potentially pathogenic microor-
This terminology is under the jurisdiction of ASTM Committee E35 on
ganisms in/on surfaces or objects.
Pesticides, Antimicrobials, and Alternative Control Agents and is the direct
responsibility of Subcommittee E35.15 on Antimicrobial Agents.
decontamination, n—a procedure that eliminates or reduces
Current edition approved Nov. 1, 2019. Published November 2019. Originally
contaminants. The usual reference is to reduce potentially
approved in 2010. Last previous edition approved in 2018 as E2756–18. DOI:
10.1520/E2756–19. harmful or undesirable microorganisms.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2756 − 19
able to recombine with electron holes within the device, releasing
disinfectant, n—a physical or chemical agent or process that
energy in the form of photons.
destroys pathogenic or potentially pathogenic microorgan-
isms in/on surfaces or objects.
low-level disinfectant, n—a disinfectant that inactivates veg-
etative bacteria, lipid viruses, and some fungi.
D-value (decimal reduction time/log death time), n—the
time or radiation dose required to achieve inactivation of
macrobacillus, n—a Bacillus endospore that possess an
90 % of one log of a population of the test microorganism
exosporium.
under stated exposure conditions.
mercury vapor lamp—a gas discharge lamp that uses electric
effectiveness, n—a measure of the performance of a product.
arc through vaporized mercury to produce light.
efficacy, n—the proven performance of a product established
microbacillus, n—a Bacillus endospore that does not possess
under defined conditions of testing.
an exosporium.
endospore, n—a dormant, robust and non-metabolically active
minimum inhibitory concentration (MIC), n—the lowest
structure produced by certain bacteria from the Firmicutes
concentration of an antimicrobial agent that prevents visible
phylum.
growth of a microorganism in an agar or broth dilution
envelope, n—a layer of host cell membrane-deprived lipid that
susceptibility test.
surrounds the capsid of some viruses.
negative control, n—material or procedure used to differenti-
exosporium, n—the outermost layer of spores of Bacillus
ate the effects of specified treatments from the uncontrolled
anthracis and its close relatives Bacillus thuringiensis and
variables in a test system.
Bacillus cereus.
neutralization, n—the process for inactivating or quenching
false negative, adj—incorrectly indicating the absence of a
the activity of a microbicide, often achieved through physi-
finding or condition.
cal (for example, filtration or dilution) or chemical means.
false positive, adj—incorrectly indicating the presence of a
persistent effect, n—prolonged antimicrobial activity mea-
finding or condition.
sured after treatment(s) that prevents or inhibits proliferation
or survival of microorganisms, or both.
fomite (fomes), n—an inanimate object that harbors patho-
genic microorganisms and may transmit infection.
positive control, n—treatment using known material or proce-
dure used to validate a test protocol.
germ, n—microorganisms pathogenic to humans.
precision,n—the closeness of agreement between independent
glove juice procedure, n—a process requiring placement of
test results obtained under prescribed conditions.
test subjects’hands into low bioburden plastic bags or sterile
gloves that are powder-free and non-antimicrobial. Stripping
preservative, n—chemical agent(s) added to a product to
solution is added to the glove, the hands are massaged, and
reduce or prevent microbial growth.
the stripping solution (glove juice) is sampled to recover
microorganisms.
radiometer, n—a device for measuring the radiant power that
hasanoutputproportionaltotheintensityoftheinputpower.
grab sample, n—single sample from process stream (flowing)
orfromsourceofconfinedgeometry(stagnant)withdrawnat
recovery control, n—a procedure that validates that initial
a specific time.
population(s) meet the criterion of a method.
inoculum,n—inmicrobiology,aspecimencomprisedofliving
reference control, n—material or procedure with known
spores, bacteria, yeast or the multicellular filamentous fungi,
performance in a test method.
orcombinationoftwoormoretypesofmicroorganisms,that
repeatability, n—the precision of test results obtained in the
are introduced into a test medium or onto a specimen to be
tested in order to investigate the ability of the medium or same laboratory under specifically defined conditions.
specimen to support microbial growth or to investigate its
reproducibility, n—the precision of test results obtained in
antimicrobial properties.
different laboratories performing the same test procedure
intermediate-level disinfectant, n—a disinfectant that inacti-
under specifically defined conditions.
vates mycobacteria, vegetative bacteria, most fungi, and
resident microbial skin flora,n—microorganismsthatsurvive
lipid and non-lipid viruses.
and multiply on the skin, forming a stable population.
irradiance (E), n—a radiometric term for the radiant flux that
room temperature, n—temperature in the range of 20 to 30°C
is incident upon a surface (W·m ).
(68 to 85°F).
light-emitting diode (LED), n—a solid-state electronic device
sanitizer, n—chemical or physical agent(s) used to reduce the
or transistor which emits light.
number of microorganisms to a level judged to be appropri-
DISCUSSION—ALED is a p-n junction diode, which emits light when
activated. When a suitable voltage is applied to the leads, electrons are ate for a defined purpose and/or claim.
-------
...

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: E2756 − 18 E2756 − 19
Standard Terminology Relating to
Antimicrobial and Antiviral Agents
This standard is issued under the fixed designation E2756; 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 The purpose of this terminology standard is to establish uniformity in terms used in the field of antimicrobial and antiviral
agent testing. Terms are adapted from related fields such as regulatory terms defined by law and definitions as supported by test
requirements.
1.2 The terms are appropriate to the wide range of interest related to standards developed in the area of antimicrobial and
antiviral testing.
1.3 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.
2. Terminology
GENERAL ANTIMICROBIAL AND ANTIVIRAL TERMS
accuracy, n—a measure of the degree of conformity of a value generated by a specific procedure to the assumed or accepted true
value, and includes both precision and bias.
ambient temperature, n—temperature of the environment in which a test method is performed.
antibacterial, adj—describes an agent that kills bacteria or suppresses their growth or reproduction.
antimicrobial, adj—describes an agent that kills or inactivates microorganisms or suppresses their growth or reproduction.
antiseptic, n—a material for use on living tissue that either destroys microorganisms or suppresses their growth.
bias, n—a systematic error that contributes to the difference between the mean of a large number of test results and an accepted
reference value (ASTM Form and Style Manual).
DISCUSSION—
A statement of bias is not possible because standard reference materials are not available for most microbiological methods.
biofilm, n—microorganisms living in a self-organized community attached to surfaces, interfaces, or each other, embedded in a
matrix of extracellular polymeric substances of microbial origin, while exhibiting altered phenotypes with respect to growth rate
and gene transcription.
biofouling, n—the unwanted accumulation of organisms and/or their products on surfaces.
cleaner-sanitizer, n—a physical or chemical agent that removes soil from an object and reduces numbers of microorganisms on
non-food contact surfaces.
carrier, n—a surrogate surface or matrix that facilitates the interaction of test microorganisms and treatment(s).
cell monolayer, n—a single layer of eukaryotic cells typically propogated on a glass or plastic surface to which they are securely
attached.
This terminology 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, 2018Nov. 1, 2019. Published June 2018November 2019. Originally approved in 2010. Last previous edition approved in 20102018 as
E2756–10.–18. DOI: 10.1520/E2756–18.10.1520/E2756–19.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2756 − 19
cleansing wash, n—a procedure intended to remove soil or residue.
clastogen, n—an agent that reduces chromosomal breakage.
composite sample, n—a series of grab samples integrated into a single sample or samples collected at specific times and integrated
into a single sample.
cooling system, n—equipment and coolant used for the removal of heat from processes, equipment, or both.
cooling water, n—any water-based solution that absorbs and transfers heat in a heat exchange system.
cumulative effect, n—a progressively additive reduction in the numbers of viable microorganisms measured from an established
baseline following repeated applications of a material or procedure.
decontaminant, n—a physical or chemical agent or process that destroys pathogenic or potentially pathogenic microorganisms
in/on surfaces or objects.
decontamination, n—a procedure that eliminates or reduces contaminants. The usual reference is to reduce potentially harmful
or undesirable microorganisms.
disinfectant, n—a physical or chemical agent or process that destroys pathogenic or potentially pathogenic microorganisms in/on
surfaces or objects.
D-value (decimal reduction time/log death time), n—the time or radiation dose required to achieve inactivation of 90 % of one
log of a population of the test microorganism under stated exposure conditions.
effectiveness, n—a measure of the performance of a product.
efficacy, n—the proven performance of a product established under defined conditions of testing.
endospore, n—a dormant, robust and non-metabolically active structure produced by certain bacteria from the Firmicutes phylum.
envelope, n—a layer of host cell membrane-deprived lipid that surrounds the capsid of some viruses.
exosporium, n—the outermost layer of spores of Bacillus anthracis and its close relatives Bacillus thuringiensis and Bacillus
cereus.
false negative, adj—incorrectly indicating the absence of a finding or condition.
false positive, adj—incorrectly indicating the presence of a finding or condition.
fomite (fomes), n—an inanimate object that harbors pathogenic microorganisms and may transmit infection.
germ, n—microorganisms pathogenic to humans.
glove juice procedure, n—a process requiring placement of test subjects’ hands into low bioburden plastic bags or sterile gloves
that are powder-free and non-antimicrobial. Stripping solution is added to the glove, the hands are massaged, and the stripping
solution (glove juice) is sampled to recover microorganisms.
grab sample, n—single sample from process stream (flowing) or from source of confined geometry (stagnant) withdrawn at a
specific time.
inoculum, n—in microbiology, a specimen comprised of living spores, bacteria, yeast or the multicellular filamentous fungi, or
combination of two or more types of microorganisms, that are introduced into a test medium or onto a specimen to be tested
in order to investigate the ability of the medium or specimen to support microbial growth or to investigate its antimicrobial
properties.
intermediate-level disinfectant, n—a disinfectant that inactivates mycobacteria, vegetative bacteria, most fungi, and lipid and
non-lipid viruses.
irradiance (E), n—a radiometric term for the radiant flux that is incident upon a surface (W·m ).
light-emitting diode (LED), n—a solid-state electronic device or transistor which emits light.
DISCUSSION—
A LED is a p-n junction diode, which emits light when activated. When a suitable voltage is applied to the leads, electrons are able to recombine with
electron holes within the device, releasing energy in the form of photons.
low-level disinfectant, n—a disinfectant that inactivates vegetative bacteria, lipid viruses, and some fungi.
E2756 − 19
macrobacillus, n—a Bacillus endospore that possess an exosporium.
mercury vapor lamp—a gas discharge lamp that uses electric arc through vaporized mercury to produce light.
microbacillus, n—a Bacillus endospore that does not possess an exosporium.
minimum inhibitory concentration (MIC), n—the lowest concentration of an antimicrobial agent that prevents visible growth
of a microorganism in an agar or broth dilution susceptibility test.
negative control, n—material or procedure used to differentiate the effects of specified treatments from the uncontrolled variables
in a test system.
neutralization, n—the process for inactivating or quenching the activity of a microbicide, often achieved through physical (for
example, filtration or dilution) or chemical means.
persistent effect, n—prolonged antimicrobial activity measured after treatment(s) that prevents or inhibits proliferation or survival
of microorganisms, or both.
positive control, n—treatment using known material or procedure used to validate a test protocol.
precision, n—the closeness of agreement between independent test results obtained under prescribed conditions.
preservative, n—chemical agent(s) added to a product to reduce or prevent microbial growth.
radiometer, n—a device for measuring the radiant power that has an output proportional to the intensity of the input power.
recovery control, n—a procedure that validates that initial population(s) meet the criterion of a method.
reference control, n—material or procedure with known performance in a test method.
repeatability, n—the precision of test results obtained in the same laboratory under specifically defined conditions.
reproducibility, n—the precision of test results obtained in different laboratories performing the same test procedure under
specifically defined conditions.
resident microbial skin flora, n—microorganisms that survive and multiply on the skin, forming a stable population.
room temperature, n—temperature in the range of 20 to 30°C (68 to 85°F).
sanitizer, n—chemical or physical agent(s) used to reduce the number
...