Historical
ASTM E1837-96(2014)
Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)
1.1 This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms.
1.2 This test method is designed to provide a reproducible procedure to verify the effectiveness of a previously validated disinfectant or disinfection procedure for reusable medical instruments and devices.
1.3 This test method is not meant to define the effectiveness of or validation of the particular disinfection process used or its kinetics, but rather, it is devised to confirm the effectiveness of the disinfection process by simulating use situations with a particular test process using medical devices and instruments. Either manual or machine reprocessing can be tested.
1.4 This test method is intended for use with reusable cleaned and previously sterilized or disinfected (high level) medical instruments and devices. Endoscopes are described in this test method as a worst-case example for contamination and sampling. The selected sterilization or disinfection processes, or both, should have been validated previously, as well as the effectiveness of rinsing for residual sterilant/disinfectant removal determined.
1.5 An inoculum with high numbers of selected microorganisms is applied to both test and control, cleaned and sterilized, or disinfected medical instruments. Strains of microorganisms with a recorded resistance to disinfectants are used to contaminate the instrument sites known or suspected to be the most difficult to reprocess.
1.6 It is impractical to test for recovery of survivors by immersion of some instruments, for example, endoscopes or some laproscopic instruments, in growth medium because of complexity, size, difficulty in long-term incubation, or deterious effects resulting from incubation. Elution of organisms from the inoculated surfaces, therefore, may be performed to estimate the number of recoverable organisms. Immersion can be used for smaller instruments.
ASTM International [astm]