ASTM E2197

1.1 The method is designed to evaluate the ability of liquid chemical germicides to inactivate vegetative bacteria, viruses, fungi, mycobacteria and bacterial spores in the presence of a soil load (1,2) on disk carriers that represent environmental surfaces and medical devices. It is also designed to have survivors that can be compared to 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 size of the test inoculum should be sufficiently large to take into account both the performance standard and the experimental variation in the results.

1.2 The test protocol does not include any wiping or rubbing action. It is, therefore, not designed for testing germicide-soaked 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 ().

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

1.5 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).

1.6 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.

2. Referenced Documents

ASTM Standards
D1129 Terminology Relating to Water
D1193 Specification for Reagent Grade Water
E1054 Practices for Evaluating Inactivators of Antimicrobial Agents Used in Disinfectant, Sanitizer, Antiseptic, or Preserved Products
E2111 Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal and Sporicidal Potencies of Liquid Chemical Germicides
CFR Standard
40CFR,Part160; 21 CFR, Part 58
Other Documents
CAN/CGSB-2.161-97, Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices

Index Terms

Adenovirus; Bacillus subtilis spores; bactericides; cell cultures; chemical germicides; Clostridium sporogenes spores; eluate; eluent; environmental surfaces; fungicides; hepatitis A virus; medical devices; membrane filtration; mycobactericides; Mycobacterium terrae; Pseudomonas aeruginosa; quantitative carrier test; rhinovirus; rotavirus; soil load; sporicides; Staphylococcus aureus; standard hard water; surrogate; Trichophyton mentagrophytes conidia; virucides; viruses; ICS Number Code 07.100.01 (Microbiology in general)

Citing ASTM Standards

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