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ASTM-E2197:2011 Edition

$44.96

E2197-11 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides

Published By Publication Date Number of Pages
ASTM 2011 13
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1.1 This test method is designed to evaluate the ability of test substances to inactivate vegetative bacteria, viruses, fungi, mycobacteria, and bacterial spores (1-7) on disk carriers of brushed stainless steel that represent hard, nonporous environmental surfaces and medical devices. It is also designed to have survivors that can be compared to the mean of no less than three control carriers to determine if the performance standard has been met. For proper statistical evaluation of the results, the number of viable organisms in the test inoculum should be sufficiently high to take into account both the performance standard and the experimental variations in the results.

1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing wipes.

1.3 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level (8) .

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).

1.5 In this test method, SI units are used for all applications, except for distance in which case inches are used and metric units follow.

1.6 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.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Summary of Test Method
Significance and Use
3 General Equipment and Labware
4 General Solutions and Reagents
Carriers
5 Soil Load
Preparation of Inocula
FIG. 1
6 FIG. 2
7 TABLE 1
8 Additional Controls in Virucidal Tests
Calculating Log10 Reductions
Precision and Bias
Keywords
A1. MICROORGANISMS COMMONLY USED IN TESTING ENVIRONMENTAL SURFACE AND MEDICAL DEVICE DISINFECTANTS, AND THEIR GROWTH AND RECOVERY MEDIA
A1.1
11 X1. ADDITIONAL CONTROLS REQUIRED WHEN ASSESSING THE VIRUCIDAL ACTIVITY OF A TEST SUBSTANCE
X1.1 Cytotoxicity Control
X1.2 Validation of Neutralization of Microbicides Used in Tests for Virucidal Activity
12 X1.3 Test to Check for Interference of Test Substance with Virus Infectivity
REFERENCES
ASTM-E2197
$44.96