ASTM E2314-03

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Designation:E2314–03
Standard Test Method for
Determination of Effectiveness of Cleaning Processes for
Reusable Medical Instruments Using a Microbiologic
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Method (Simulated Use Test)
This standard is issued under the fixed designation E 2314; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Cleaning is acknowledged as the critical first step in the reprocessing of reusable medical
instruments. A test method to examine the efficacy and reproducibility of cleaning procedures would
be valuable in optimizing decontamination of medical instruments, as well as increasing the margin
of safety of subsequent disinfection and sterilization procedures. This test method is a means of
determining the efficacy of the instrument manufacturer’s cleaning instructions. In this simulated use
test cleaning steps are performed with the instruments in a controlled laboratory environment. Within
this environment, various parameters may be exaggerated to create worst-case conditions for the test.
Among these are the amount or type of organic soil or micro-organisms contaminating the
instruments.
The test method was developed primarily for large medical instruments or instruments with internal
channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical
instruments. It employs both direct inoculation and sampling methods for external surfaces and
indirect inoculation and sampling methods for less accessible internal channels.
Cleaning is defined as the removal of foreign materials, most often mixtures of organic soil (for
example, protein) and microorganisms, from medical instruments. Bacterial endospores are the
preferred microorganisms in this simulated test because they would be more resistant to the potential
microbiocidal effects of the cleaning processes and solutions. This method examines the reduction in
the number of spores as a tracer of foreign materials and not necessarily the reduction in organic soil
directly.
This test may be designed to either examine the efficacy of a complete cleaning cycle consisting of
several integrated steps or individual cleaning step such as precleaning, manual cleaning, automated
cleaning or rinsing.
1. Scope 1.3 The test method utilizes bacterial spores as tracers for
foreign materials and quantifies their removal as a means of
1.1 This test method is written principally for large medical
determining the efficacy of a cleaning process.
instruments or instruments with internal channels or recesses
1.4 The test method is designed for use by manufacturers of
(for example, flexible endoscopes) but may be used for any
medical instruments and devices. However, it may also be
resuable medical instruments.
employed by other individuals who have a knowledge of the
1.2 This test method describes a procedure for testing the
instruments, techniques and access to appropriate facilities.
efficacy of a cleaning process for reusable medical instruments
1.5 Worst-case conditions can be represented by exaggerat-
artificially contaminated with mixtures of microorganisms and
ing a specific test parameter or otherwise intentionally simu-
simulated soil.
lating an extreme condition such as performing the test without
cleaning solutions or utilizing instruments which are not new.
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This test method is under the jurisdiction of ASTM Committee E35 on
1.6 The test procedure is devised to determine the efficacy
Pesticides and Alternative Control Agents and is the direct responsibility of
of a cleaning process as applied to a particular instrument or
Subcommittee E35.15 on Antimicrobial Agents.
group of instruments by simulating actual use situations.
Current edition approved Oct. 1, 2003. Published November 2003.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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E2314–03
1.7 The test procedure may be performed on test instru- 3.1.1 accessible location—a location on a reusable medical
ments using a complete cleaning cycle or be limited to instrument(s) that may be contacted by bioburden, soil and
particular phases of the cycle such as precleaning, manual cleaning agents.
cleaning, automated cleaning, or rinsing. 3.1.2 automated cleaning—the removal of foreign material
1.8 The test procedure is normally performed on a number
from medical instruments by means of a machine.
of external and internal sites, but it may be restricted to one 3.1.3 bioburden—the number and types of viable microor-
particular site on the instrument.
ganisms that contam
...