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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Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) (Withdrawn 2021)
Automatically translated name:
Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)
STANDARD published on 1.10.2014
The information about the standard:
Designation standards: ASTM E2314-03(2014)
Note: WITHDRAWN
Publication date standards: 1.10.2014
SKU: NS-45012
The number of pages: 6
Approximate weight : 18 g (0.04 lbs)
Country: American technical standard
Category: Technical standards ASTM
The category - similar standards:
Annotation of standard text ASTM E2314-03(2014) :
Keywords:
cleaning, cleaning solution, endoscope, recovery and elution, reprocessing, reusable medical instrument,, ICS Number Code 11.080.99 (Other standards related to sterilization and disinfection)
Additional information
| Significance and Use | ||||||||
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5.1 This test method is designed to evaluate the effectiveness of cleaning reusable medical instruments using a specified cleaning process. 5.2 This test method may be used to determine the effectiveness of cleaning processes of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical instruments. 5.3 This test method may also be used to verify the claims for any portion of the cleaning cycle. 5.4 The recovery of surviving microorganisms may be accomplished using swabbing, rinsing, or total immersion of instruments. 5.5 The efficacy of the elution methods or loss of the applied inoculum may be assessed by recovery of target organisms from control instruments that have not been subjected to the cleaning process. |
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| 1. Scope | ||||||||
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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. 1.8 The test procedure is normally performed on a number of external and internal sites, but it may be restricted to one particular site on the instrument. 1.9 A knowledge of microbiological and aseptic techniques and familiarity with the instruments is required to conduct these procedures. Note 1: Because contamination of the surfaces of instruments
may occur as a result of rinsing with tap water, bacteria-free
water should be used for all rinsing when a water rinse step is
part of the cleaning directions.
Note 2: Test methods to determine the effectiveness of
cleaning medical instruments has only recently been actively
debated, and research efforts are in their infancy. Because
published experimental results are scarce, it is premature to
dictate experimental reagents, conditions or acceptance
criteria.
Note 3: The total elimination of the target organisms is not
the goal of cleaning. Therefore, there will almost always be a
number of microorganisms surviving on the test instruments unless
one of the solutions or processes disinfects or sterilizes the test
instrument. The results of various clinical and laboratory tests
suggest that cleaning processes alone can produce a 102
to 104 log10 reduction in bioburden. The
exact reduction will depend upon the precise experimental
conditions. The criteria for judging cleanliness should be
determined and recorded before initiation of the test
procedure.
Note 4: This test protocol employs target spores as indicators
or tracers for foreign materials and monitors their removal by the
cleaning process. It is certainly possible that other particulate
target materials, such as microbeads (latex beads) could be used in
place of microbes. These alternate approaches would be more
practical in those circumstances where microbiological expertise is
limited.
1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.11 This standard may involve hazardous materials, operations, and equipment. 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. |
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| 2. Referenced Documents | ||||||||
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