ASTM E1053-97
(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
SCOPE
1.1 This laboratory test method is used to evaluate the virucidal efficacy of disinfectant solutions or pressurized disinfectant spray products on inanimate nonporous environmental surfaces. This test method is designed to be performed by persons with training in virology. This test method may be employed with most viruses and is designed for embryonated eggs or tissue 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.
1.4 It is the responsibility of the investigator 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.
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: E 1053 – 97
Standard Test Method for
Efficacy of Virucidal Agents Intended for Inanimate
Environmental Surfaces
This standard is issued under the fixed designation E 1053; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope Drug Administration, Part 58, Laboratory Practice for
Nonclinical Laboratory Studies
1.1 This laboratory test method is used to evaluate the
virucidal efficacy of liquid, aerosol, or trigger spray antimicro-
3. Summary of Test Method
bial solutions on inanimate nonporous environmental surfaces.
3.1 The virus suspension is dried on an inanimate, nonpo-
This test method may be employed with most viruses and is
rous surface. The antimicrobial is added over the dried film as
designed for cell culture host systems.
a use dilution solution or sprayed from an aerosol can or trigger
1.2 This test method should be performed only by those
spray container following the recommended directions. After
trained in microbiological or virological techniques.
exposure at the appropriate temperature (usually 22 6 2°C) for
1.3 This standard does not purport to address all of the
the recommended time, the virus-antimicrobial mixture is
safety concerns, if any, associated with its use. It is the
assayed in a host system appropriate for the test virus. The
responsibility of the user of this standard to establish appro-
virus titer of an untreated surface is determined by the median
priate safety and health practices and determine the applica-
infective dose (ID ) method of virus titration. Cytotoxicity to
bility of regulatory limitations prior to use. The user should
the host system of the antimicrobial at the tested concentration
consult a reference for the laboratory safety recommenda-
2 is determined by an LD method. The virus-antimicrobial
tions.
mixture is assayed in numerous units of the host system at a
1.4 It is the responsibility of the investigator to determine
dilution just beyond the cytotoxicity range of the antimicrobial.
whether Good Laboratory Practice regulations (GLPs) are
The extent of virus inactivation by the antimicrobial is deter-
required and to follow them where appropriate (40 CFR, Part
mined. Results are recorded as log -virus inactivated.
160 for EPA submissions and 21 CFR, Part 58 for FDA
3.2 This test method is designed to be performed by a
submissions). Refer to the appropriate regulatory agency for
trained virologist who is responsible for choosing the appro-
performance standards of virucidal efficacy.
priate host system for the test virus and applying the techniques
2. Referenced Documents necessary for propagation and maintenance of host and test
virus. For a reference text, refer to Schmidt and Emmons.
2.1 ASTM Standards:
E 1052 Test Method for Efficacy of Virucidal Agents
4. Significance and Use
Against Viruses in Suspensions
4.1 This test method may be used to determine the effec-
E 1153 Test Method for Efficacy of Sanitizers Recom-
3 tiveness of liquid and aerosol antimicrobial products against
mended for Inanimate Non-Food Contact Surfaces
designated prototype viruses.
E 1482 Test Method for Neutralization of Virucidal Agents
3 4.2 The effective antimicrobial concentration should be
in Virucidal Efficacy Evaluations
determined utilizing cell cultures as the host system for specific
2.2 Federal Standards:
viruses.
Title 40, Code of Federal Regulations (CFR), Environmen-
4.3 This test method is applicable for testing of liquid and
tal Protection Agency, Subchapter E, Pesticide Programs;
4 pressurized antimicrobial products against viruses on inani-
Part 160, Good Laboratory Practice Standards
mate nonporous environmental surfaces.
Title 21, Code of Federal Regulations (CFR), Food and
5. Materials and Reagents
This test method is under the jurisdiction of ASTM Committee E-35 on 5
5.1 Cell Culture Technique:
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial
5.1.1 Cell Culture System, appropriate for test virus.
Agents.
5.1.2 Growth Media/Maintenance Media, Medium 199, Ea-
Current edition approved April 10, 1997. Published June 1997. Originally
published as E 1053 – 85. Last previous edition E 1053 – 91.
gle’s minimal essential medium (EMEM) or equivalent,
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, 3rd ed.,
U.S. Department of Health and Human Services, Washington, DC, May 1993.
3 5
Annual Book of ASTM Standards, Vol 11.05. Diagnostic Procedures for Viral and Rickettsial Infections, N. J. Schmidt and R.
Available from U.S. Government Printing Office, Superintendent of Docu- W. Emmons, eds., 6th ed., American Public Health Association, Washington, DC,
ments, Washington, DC 20402. 1989.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
E 1053
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.
NOTE 1—Rhinovirus-infected cultures require incubation at 33 6 1°C.
5.1.9 Microtitration Kit.
6.3.10 Rotavirus, Wa strain, ATCC VR-2018.
5.1.10 Petri Plates, glass, 60-mm diameter, 1 cm deep.
Cell line options: Rhesus Monkey Kidney, Continuous
5.2 Additional or equivalent materials and reagents specific
(MA-104) or
to the host recovery system may be necessary. The trained
African Green Monkey Kidney, Continuous (CV-1).
microbiologist or virologist is responsible to choose accord-
ingly as needed.
NOTE 2—Some lots of fetal calf serum may be inhibitory to rotavirus.
6.4 Other Viral Groups—Virucidal efficacy against certain
6. Test Viruses
types of viruses such as Human Immunodeficiency Virus must
6.1 To determine virucidal efficacy, a prototype strain from
be substantiated in a laboratory having Biosafety Level 3
a particular virus family must be tested. Because new strains of
Facilities.
viruses are being discovered continuously and methods of
isolation and growth are being improved, the following proto- 7. Virus Stock
types and the cell cultures in which to grow and test them are
7.1 The titer of the test virus suspension must be sufficiently
suggested. Other strains within a family may be substituted as
high so that at least 10 infective units may be recovered from
testing prototypes for specific marketing claims.
the dried films as described as follows. Utilize an appropriate
6.2 To
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