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 |
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 |
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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 |