ASTM E1053-97(2002)
(Test Method)Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
SIGNIFICANCE AND USE
This test method may be used to determine the effectiveness of liquid and aerosol antimicrobial products against designated prototype viruses.
The effective antimicrobial concentration should be determined utilizing cell cultures as the host system for specific viruses.
This test method is applicable for testing of liquid and pressurized antimicrobial products against viruses on inanimate nonporous environmental surfaces.
SCOPE
1.1 This laboratory test method is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger spray antimicrobial solutions on inanimate nonporous environmental surfaces. This test method may be employed with most viruses and is designed for cell culture host systems.
1.2 This test method should be performed only by those trained in microbiological or virological techniques.
1.3 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. The user should consult a reference for the laboratory safety recommendations.
1.4 It is the responsibility of the invesigator to determine whether Good Laboratory Practice regulations (GLPs) are required and to follow them where appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR, Part 58 for FDA submissions). Refer to the appropriate regulatory agency for performance standards of virucidal efficacy.
General Information
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Standards Content (Sample)
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Designation:E1053–97 (Reapproved 2002)
Standard Test Method for
Efficacy of Virucidal Agents Intended for Inanimate
Environmental Surfaces
This standard is issued under the fixed designation E1053; 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 tal ProtectionAgency, Subchapter E, Pesticide Programs;
Part 160, Good Laboratory Practice Standards
1.1 This laboratory test method is used to evaluate the
Title 21, Code of Federal Regulations (CFR), Food and
virucidal efficacy of liquid, aerosol, or trigger spray antimicro-
Drug Administration, Part 58, Laboratory Practice for
bial solutions on inanimate nonporous environmental surfaces.
Nonclinical Laboratory Studies
This test method may be employed with most viruses and is
designed for cell culture host systems.
3. Summary of Test Method
1.2 This test method should be performed only by those
3.1 The virus suspension is dried on an inanimate, nonpo-
trained in microbiological or virological techniques.
rous surface. The antimicrobial is added over the dried film as
1.3 This standard does not purport to address all of the
ausedilutionsolutionorsprayedfromanaerosolcanortrigger
safety concerns, if any, associated with its use. It is the
spray container following the recommended directions. After
responsibility of the user of this standard to establish appro-
exposureattheappropriatetemperature(usually22 62°C)for
priate safety and health practices and determine the applica-
the recommended time, the virus-antimicrobial mixture is
bility of regulatory limitations prior to use. The user should
assayed in a host system appropriate for the test virus. The
consult a reference for the laboratory safety recommenda-
2 virus titer of an untreated surface is determined by the median
tions.
infective dose (ID ) method of virus titration. Cytotoxicity to
1.4 It is the responsibility of the investigator to determine
the host system of the antimicrobial at the tested concentration
whether Good Laboratory Practice regulations (GLPs) are
is determined by an LD method. The virus-antimicrobial
required and to follow them where appropriate (40 CFR, Part
mixture is assayed in numerous units of the host system at a
160 for EPA submissions and 21 CFR, Part 58 for FDA
dilutionjustbeyondthecytotoxicityrangeoftheantimicrobial.
submissions). Refer to the appropriate regulatory agency for
The extent of virus inactivation by the antimicrobial is deter-
performance standards of virucidal efficacy.
mined. Results are recorded as log -virus inactivated.
2. Referenced Documents 3.2 This test method is designed to be performed by a
3 trained virologist who is responsible for choosing the appro-
2.1 ASTM Standards:
priatehostsystemforthetestvirusandapplyingthetechniques
E1052 Test Method for Efficacy of Antimicrobial Agents
necessary for propagation and maintenance of host and test
Against Viruses in Suspension
virus. For a reference text, refer to Schmidt and Emmons.
E1153 Test Method for Efficacy of Sanitizers Recom-
mended for Inanimate Non-Food Contact Surfaces
4. Significance and Use
E1482 Test Method for Neutralization of Virucidal Agents
4.1 This test method may be used to determine the effec-
in Virucidal Efficacy Evaluations
tiveness of liquid and aerosol antimicrobial products against
2.2 Federal Standards:
designated prototype viruses.
Title 40, Code of Federal Regulations (CFR), Environmen-
4.2 The effective antimicrobial concentration should be
determinedutilizingcellculturesasthehostsystemforspecific
viruses.
This test method is under the jurisdiction of ASTM Committee E35 on
PesticidesandisthedirectresponsibilityofSubcommitteeE35.15onAntimicrobial
4.3 This test method is applicable for testing of liquid and
Agents.
pressurized antimicrobial products against viruses on inani-
Current edition approved April 10, 1997. Published June 1997. Originally
mate nonporous environmental surfaces.
published as E1053–85. Last previous edition E1053–91. DOI: 10.1520/E1053-
97R02.
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories,3rded.,
U.S. Department of Health and Human Services, Washington, DC, May 1993. Available from U.S. Government Printing Office, Superintendent of Docu-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or ments, Washington, DC 20402.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM DiagnosticProceduresforViralandRickettsialInfections,N.J.SchmidtandR.
Standards volume information, refer to the standard’s Document Summary page on W. Emmons, eds., 6th ed., American Public Health Association, Washington, DC,
the ASTM website. 1989.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1053–97 (2002)
5. Materials and Reagents 6.3.3 Herpes Simplex, Type 1, Strain F (1),ATCC VR-733.
Cell line options: VERO, HEp-2.
5.1 Cell Culture Technique:
6.3.4 Cytomegalovirus, strain AD-169, ATCC VR-538.
5.1.1 Cell Culture System, appropriate for test virus.
Cell line options: Human Diploid Lung (MRC-5 or
5.1.2 Growth Media/Maintenance Media, Medium 199, Ea-
WI-38).
gle’s minimal essential medium (EMEM) or equivalent,
6.3.5 Adenovirus, Type 2, Adenoid 6 strain, ATCC VR-2.
supplemented with appropriate concentration of serum (inac-
Cell line options: Human Lung Carcinoma (A549),
tivated and mycoplasma-free), antibiotics, and other growth
HEp-2.
factors as needed.
6.3.6 Influenza A , Hong Kong Strain, ATCC VR-544.
5.1.3 Diluent, the media listed in 5.1.2, phosphate buffered
Cell line options: Canine Kidney (MDCK); Rhesus Mon-
saline, trypticase soy broth supplemented with serum or other
key Cells, Continuous (LLC-MK2).
similar buffered solutions.
6.3.7 Respiratory Syncytial Virus, Long strain, ATCC VR-
5.1.4 Plastic Cell Culture Ware.
26.
5.1.5 Incubator, capable of maintaining 37 6 1°C or other
Cell line options: HEp-2, MRC-5.
temperature appropriate for replication of the specific test
6.3.8 Vaccinia, WR strain, ATCC VR-119.
virus.
Cell line options: VERO, HEp-2.
5.1.6 Refrigerator,4 6 2°C.
6.3.9 Rhinovirus, Type 37, Strain 151-1, ATCC VR-1147.
5.1.7 Test Tubes, screw-capped.
Cell line options: MRC-5, WI-38.
5.1.8 Pipettes, serological, 10, 1, and 0.5 mL.
5.1.9 Microtitration Kit.
NOTE 1—Rhinovirus-infected cultures require incubation at 33 6 1°C.
5.1.10 Petri Plates, glass, 60-mm diameter, 1 cm deep.
6.3.10 Rotavirus, Wa strain, ATCC VR-2018.
5.2 Additional or equivalent materials and reagents specific
Cell line options: Rhesus Monkey Kidney, Continuous
to the host recovery system may be necessary. The trained
(MA-104) or
microbiologist or virologist is responsible to choose accord-
African Green Monkey Kidney, Continuous (CV-1).
ingly as needed.
NOTE 2—Some lots of fetal calf serum may be inhibitory to rotavirus.
6. Test Viruses
6.4 Other Viral Groups—Virucidal efficacy against certain
6.1 To determine virucidal efficacy, a prototype strain from types of viruses such as Human Immunodeficiency Virus must
aparticularvirusfamilymustbetested.Becausenewstrainsof
be substantiated in a laboratory having Biosafety Level 3
viruses are being discovered continuously and methods of Facilities.
isolation and growth are being improved, the following pr
...
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