ASTM E2197
Scope
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on
Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Keywords
adenovirus; Aspergillus aculeatinus conidia; Bacillus spizizenii spores; bactericides; calicivirus; Candida albicans; cell cultures; chemical microbicides; Clostridium sporogenes spores; eluate;
eluent; environmental surfaces; fungicides; hepatitis A virus; medical devices; membrane filtration; mycobactericides; Mycobacterium terrae; norovirus; parvovirus; Pseudomonas aeruginosa;
quantitative carrier test; rhinovirus; rotavirus; soil load; sporicides; Staphylococcus aureus; standard hard water; surrogate; Trichophyton interdigitale conidia; virucides; viruses;
ICS Code
ICS Number Code 07.100.01 (Microbiology in general)
DOI: 10.1520/E2197-24