ASTM E2197-17e1
Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals

Standard No.

ASTM E2197-17e1

Release Date

2017

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM E2197-17e1

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.

ASTM E2197-17e1 Referenced Document

• ASTM A967/A967M Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts*， 2024-04-21 Update
• ASTM D1129 Standard Terminology Relating to Water
• ASTM D1193 Standard Specification for Reagent Water
• ASTM E2756 Standard Terminology Relating to Antimicrobial and Antiviral Agents*， 2019-11-01 Update

ASTM E2197-17e1 history

• 2017 ASTM E2197-17e1 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
• 2017 ASTM E2197-17 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
• 2011 ASTM E2197-11 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
• 2002 ASTM E2197-02 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides