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.

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Publication Date
30-Apr-2010
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ASTM E2756-10 - Standard Terminology Relating to Antimicrobial and Antiviral Agents
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E2756 − 10
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 carrier, n—a surrogate surface or matrix that facilitates the
interaction of test microorganisms and treatment(s).
1.1 The purpose of this terminology standard is to establish
uniformity in terms used in the field of antimicrobial and
cell monolayer, n—a single layer of eukaryotic cells typically
antiviral agent testing. Terms are adapted from related fields
propogated on a glass or plastic surface to which they are
such as regulatory terms defined by law and definitions as
securely attached.
supported by test requirements.
cleansing wash, n—a procedure intended to remove soil or
1.2 The terms are appropriate to the wide range of interest
residue.
related to standards developed in the area of antimicrobial and
antiviral testing.
clastogen, n—an agent that reduces chromosomal breakage.
2. Terminology composite sample, n—a series of grab samples integrated into
a single sample or samples collected at specific times and
GENERAL ANTIMICROBIAL AND ANTIVIRAL
integrated into a single sample.
TERMS
cooling system, n—equipment and coolant used for the re-
accuracy, n—a measure of the degree of conformity of a value
moval of heat from processes, equipment, or both.
generatedbyaspecificproceduretotheassumedoraccepted
true value, and includes both precision and bias. cooling water, n—any water-based solution that absorbs and
transfers heat in cooling systems.
ambient temperature, n—temperature of the environment in
which a test method is performed.
cumulative effect, n—a progressively additive reduction in the
numbers of viable microorganisms measured from an estab-
antibacterial, adj—describes an agent that kills bacteria or
lished baseline following repeated applications of a material
suppresses their growth or reproduction.
or procedure.
antimicrobial, adj—describes an agent that kills or inactivates
decontamination, n—a procedure that eliminates or reduces
microorganisms or suppresses their growth or reproduction.
contaminants. The usual reference is to reduce potentially
antiseptic, n—a material for use on living tissue that either
harmful or undesirable microorganisms.
destroys microorganisms or suppresses their growth.
disinfectant, n—a physical or chemical agent or process that
bias, n—a systematic error that contributes to the difference
destroys pathogenic or potentially pathogenic microorgan-
between the mean of a large number of test results and an
isms in/on surfaces or objects.
accepted reference value (ASTM Form and Style Manual).
D-value (decimal reduction time/log death time), n—the
DISCUSSION—A statement of bias is not possible because standard
time or radiation dose required to achieve inactivation of
reference materials are not available for most microbiological methods.
90 % of one log of a population of the test microorganism
biofouling, n—the unwanted accumulation of organisms
under stated exposure conditions.
and/or their products on surfaces.
effectiveness, n—a measure of the performance of a product.
cleaner-sanitizer, n—a physical or chemical agent that re-
moves soil from an object and reduces numbers of microor-
efficacy, n—the proven performance of a product established
ganisms on non-food contact surfaces.
under defined conditions of testing.
envelope, n—a layer of host cell membrane-deprived lipid that
This terminology is under the jurisdiction of ASTM Committee E35 on
surrounds the capsid of some viruses.
Pesticides and Alternative Control Agents and is the direct responsibility of
Subcommittee E35.15 on Antimicrobial Agents.
false negative, adj—incorrectly indicating the absence of a
Current edition approved May 1, 2010. Published December 2010. DOI:
10.1520/E2756–10. finding or condition.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2756 − 10
false positive, adj—incorrectly indicating the presence of a preservative, n—chemical agent(s) added to a product to
finding or condition. reduce or prevent microbial growth.
fomite (fomes), n—an inanimate object that harbors patho-
recovery control, n—a procedure that validates that initial
genic microorganisms and may transmit infection.
population(s) meet the criterion of a method.
germ, n—microorganisms pathogenic to humans.
reference control, n—material or procedure with known
performance in a test method.
glove juice procedure, n—a process requiring placement of
test subjects’hands into low bioburden plastic bags or sterile
repeatability, n—the precision of test results obtained in the
gloves that are powder-free and non-antimicrobial. Stripping
same laboratory under specifically defined conditions.
solution is added to the glove, the hands are massaged, and
reproducibility, n—the precision of test results obtained in
the stripping solution (glove juice) is sampled to recover
different laboratories performing the same test procedure
microorganisms.
under specifically defined conditions.
grab sample, n—single sample from process stream (flowing)
orfromsourceofconfinedgeometry(stagnant)withdrawnat resident microbial skin flora,n—microorganismsthatsurvive
a specific time.
and multiply on the skin, forming a stable population.
inoculum, n—the viable microorganisms used to contaminate
room temperature, n—temperature in the range of 20 to 30°C
a sample, device, or surface, often expressed as to number
(68 to 85°F).
and type.
sanitizer, n—chemical or physical agent(s) used to reduce the
intermediate-level disinfectant, n—a disinfectant that inacti-
number of microorganisms to a level judged to be appropri-
vates mycobacteria, vegetative bacteria, most fungi, and
ate for a defined purpose and/or claim.
lipid and non-lipid viruses.
slimicide, n—chemical agent(s) added to a process to reduce
low-level disinfectant, n—a disinfectant that inactivates veg-
the number of slime-forming microorganisms.
etative bacteria, lipid viruses, and some fungi.
sterilant,n—chemicalorphysicalagent(s)thatkillallformsof
minimum inhibitory concentration (MIC), n—the lowest
microorganisms in the inanimate environment.
concentration of an antimicrobial agent that prevents visible
growth of a microorganism in an agar or broth dilution
surrogate microorganism, n—microorganism that is tested to
susceptibility test.
estimate responses of other microorganism(s) for which
direct testing is impractical.
negative control, n—material or procedure used to differenti-
ate the effects of specified treatments from the uncontrolled
transient microbial skin flora, n—microorganisms that con-
variables in a test system.
taminate the skin but do not form a stable population.
neutralization, n—the process for inactivating or quenching
treated materials or articles, n—plastic, textile, or other
the activity of a microbicide, often achieved through physi-
pre-formed articles pretreated with antimicrobial products
cal (for example, filtration or dilution) or chemical means.
before fir
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