SUPERSEDED (click for Active standard)
| ||Format||Pages||Price|| |
|13||$69.00||  ADD TO CART|
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
CEN StandardEN 10088-2 1J/2J
A967/A967M Specification for Chemical Passivation Treatments for Stainless Steel Parts
D1129 Terminology Relating to Water
D1193 Specification for Reagent Water
E2756 Terminology Relating to Antimicrobial and Antiviral Agents
CFR Standard21 CFR, Part 58 Laboratory Practice for Nonclinical Laboratory Studies 40 CFR, Part 160 Good Laboratory Practice Standards
ICS Number Code 07.100.01 (Microbiology in general)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM E2197-11, Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides, ASTM International, West Conshohocken, PA, 2011, www.astm.orgBack to Top