ASTM E1052-96

Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension

SCOPE
1.1 This laboratory test method is a suspension test used to evaluate the effectiveness of antimicrobial solutions against specific viruses. 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 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.

General Information

• Status: Historical
• Publication Date: 09-Oct-1996
• Technical Committee: E35 - Pesticides, Antimicrobials, and Alternative Control Agents
• Drafting Committee: E35.15 - Antimicrobial Agents

Relations

• Replaced By: ASTM E1052-96(2002) - Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension (Withdrawn 2011)
• Effective Date: 10-Oct-1996
• Referred By: ASTM E2721-16 - Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses (Withdrawn 2024)
• Effective Date: 10-Oct-1996
• Referred By: ASTM E1482-23 - Standard Practice for Use of Gel Filtration Columns for Cytotoxicity Reduction and Neutralization
• Effective Date: 10-Oct-1996

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.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.
Designation: E 1052 – 96
Standard Test Method for
Efficacy of Antimicrobial Agents Against Viruses in
Suspension
This standard is issued under the fixed designation E 1052; 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 a suspension test used to
evaluate the effectiveness of antimicrobial solutions against
3. Summary of Test Method
specific viruses. This test method may be employed with most
3.1 One part of the virus suspension is added to nine parts of
viruses and is designed for cell culture host systems.
the appropriately diluted antimicrobial. The virus is exposed to
1.2 This test method should be performed only by those
the virucide for the length of time that is representative of
trained in microbiological or virological techniques.
actual use conditions or the label directions of the product (for
1.3 This standard does not purport to address all of the
example, from 15 sec for a handsoap to 10 min or longer for a
safety concerns, if any, associated with its use. It is the
antimicrobial solution). The tests also should be performed at
responsibility of the user of this standard to establish appro-
the temperature most representative of actual use conditions
priate safety and health practices and determine the applica-
(usually 22 6 2°C). The virus-antimicrobial mixture is assayed
bility of regulatory limitations prior to use. The user should
in a host system appropriate for the test virus. The virus titer of
consult a reference for the laboratory safety recommenda-
2 the stock virus is determined by the median cell culture
tions.
infective dose (CCID ), plaque assay or other quantifiable
1.4 It is the responsibility of the investigator to determine
measure of infectivity. Cytotoxicity to the host system (from
whether Good Laboratory Practice regulations (GLPs) are
the antimicrobial) at the tested concentration also is deter-
required and to follow them where appropriate (40 CFR, Part
mined. The virus-antimicrobial mixture is assayed in numerous
160 for EPA submissions andCFR, Part 58 for FDA submis-
units of the host system at a dilution just beyond the cytotoxic
sions). Refer to the appropriate regulatory agency for perfor-
range of the antimicrobial. At least three replicate determina-
mance standards of virucidal efficacy.
tions are performed on controls and experimentals to confirm
2. Referenced Documents virus inactivation by a batch of antimicrobial. Results are
recorded as the median value of log -virus inactivation.
2.1 ASTM Standards:
3.2 This test method is designed to be performed by a
E 1053 Test Method for Efficacy of Virucidal Agents In-
trained microbiologist or virologist who is responsible for
tended for Inanimate Environmental Surfaces
choosing the appropriate host system for the test virus, and
E 1153 Test Method for Efficacy of Sanitizers Recom-
applying the techniques necessary for propagation and main-
mended for Inanimate Non-Food Contact Surfaces
tenance of host and test virus. For a reference text, refer to
E 1482 Test Method for Neutralization of Virucidal Agents
Schmidt and Emmons.
in Virucidal Efficacy Evaluation
2.2 Federal Standards:
4. Significance and Use
Title 40, Code of Federal Regulations (CFR), Environmen-
4.1 This test method is to be used to determine the effec-
tal Protection Agency, Part 160, Good Laboratory Practice
tiveness of antimicrobial solutions against designated proto-
Standard
type viruses that are in suspension.
Title 21, Code of Federal Regulations (CFR), Food and
4.2 The effective antimicrobial concentration should be
determined using cell cultures as the host system for specific
This test method is under the jurisdiction of ASTM Committee E-35 on
viruses.
Pesticides and is the direct responsibility of Subcommittee E35.15 on Antimicrobial
4.3 This suspension test is for special applications of viru-
Agents.
cides, such as inactivation of viruses in contaminated liquid
Current edition approved Oct. 10, 1996. Published December 1996. Originally
published as E 1052 – 85. Last previous edition E 1052 – 85 (1990). wastes, and as a first stage in determining virucidal potential of
CDC-NIH, Biosafety in Microbiological and Biomedical Laboratories, Third
Edition, 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, Rickettsial and Chlamydial Infections,N.J.
Available from U.S. Government Printing Office, Superintendent of Docu- Schmidt and W. W. Emmons, Eds, Sixth Edition, Amer. Pub. Hlth. Assoc.,
ments, Washington, DC 20402. Washington, DC 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 1052
liquid chemical germicides, liquid hand soaps, OTC topicals or Cell line options: Fetal Kidney, Rhesus Monkey, Continuous
other skin products. Regulatory agencies may require addi- (FRhK-4).
tional tests to demonstrate overall virucidal activity. 6.3.3 Herpes simplex, Type 1, strain F (1), ATCC VR-733.
Cell line options: VERO, HEp-2.
5. Materials and Reagents
6.3.4 Cytomegalovirus, strain AD-169, ATCC VR-538. Cell
5.1 Cell Culture Technique.
line options: Human Diploid Lung (MRC-5 or WI-38).
5.1.1 Cell Culture System appropriate for test virus. 6.3.5 Adenovirus, Type 2, Adenoid 6 strain, ATCC VR-2.
5.1.2 Growth Media/Maintenance Media, Medium 199, Ea-
Cell line options: Human Lung Carcinoma (A549), Hep-2.
gle’s minimal essential medium (EMEM) or equivalent,
6.3.6 Influenza A , Hong Kong Strain, ATCC VR-544. Cell
supplemented with appropriate concentration of serum (inac-
line options: Canine Kidney (MDCK); Rhesus Monkey Cells,
tivated and mycoplasma-free), antibiotics and other growth
Continuous (LLC-MK2).
factors as needed.
6.3.7 Respiratory Syncytial Virus, Long strain, ATCC VR-
5.1.3 Diluent, The media listed in 5.1.2, phosphate buffered
26. Cell line options: HEp-2, MRC-5.
saline, trypticase soy broth supplemented with serum or other
6.3.8 Vaccinia, WR strain, ATCC VR-119. Cell line options:
similar buffered solutions.
VERO, HEp-2.
5.1.4 Plastic Cell Culture Ware.
6.3.9 Rhinovirus, Type 37, strain 151-1, ATCC VR-1147.
5.1.5 Incubator, capable of maintaining 37 6 1°C or other
Cell line options: MRC-5, WI-38.
temperature appropriate for the specific test virus.
NOTE 1—Rhinovirus-infected cultures require incubation at 33 6 1°C.
5.1.6 Refrigerator,4 6 2°C or other appropriate tempera-
6.3.10 Rotavirus, Wa strain, ATCC VR-2018. Cell line
ture.
options: Rhesus Monkey Kidney, Continuous (MA-104) or
5.1.7 Test Tubes, screw-capped.
African Green Monkey Kidney, Continuous (CV-1).
5.1.8 Pipettes, serological, 10, 1, 0.5 mL or calibrated
...