Historical
ASTM E2314-03(2014)
Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
1.1 This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments.
1.2 This test method describes a procedure for testing the efficacy of a cleaning process for reusable medical instruments artificially contaminated with mixtures of microorganisms and simulated soil.
1.3 The test method utilizes bacterial spores as tracers for foreign materials and quantifies their removal as a means of determining the efficacy of a cleaning process.
1.4 The test method is designed for use by manufacturers of medical instruments and devices. However, it may also be employed by other individuals who have a knowledge of the instruments, techniques and access to appropriate facilities.
1.5 Worst-case conditions can be represented by exaggerating a specific test parameter or otherwise intentionally simulating an extreme condition such as performing the test without cleaning solutions or utilizing instruments which are not new.
1.6 The test procedure is devised to determine the efficacy of a cleaning process as applied to a particular instrument or group of instruments by simulating actual use situations.
1.7 The test procedure may be performed on test instruments using a complete cleaning cycle or be limited to particular phases of the cycle such as precleaning, manual cleaning, automated cleaning, or rinsing.
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