ASTM_E_2314_-_03_2014.pdf

Designation:E231403(Reapproved 2014)Standard Test Method forDetermination of Effectiveness of Cleaning Processes forReusable Medical Instruments Using a MicrobiologicMethod(Simulated Use Test)1This standard is issued under the fixed designation E2314;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.INTRODUCTIONCleaning is acknowledged as the critical first step in the reprocessing of reusable medicalinstruments.A test method to examine the efficacy and reproducibility of cleaning procedures wouldbe valuable in optimizing decontamination of medical instruments,as well as increasing the marginof safety of subsequent disinfection and sterilization procedures.This test method is a means ofdetermining the efficacy of the instrument manufacturers cleaning instructions.In this simulated usetest cleaning steps are performed with the instruments in a controlled laboratory environment.Withinthis 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 microorganisms contaminating the instruments.The test method was developed primarily for large medical instruments or instruments with internalchannels or recesses(for example,flexible endoscopes)but may be used for any resuable medicalinstruments.It employs both direct inoculation and sampling methods for external surfaces andindirect inoculation and sampling methods for less accessible internal channels.Cleaning is defined as the removal of foreign materials,most often mixtures of organic soil(forexample,protein)and microorganisms,from medical instruments.Bacterial endospores are thepreferred microorganisms in this simulated test because they would be more resistant to the potentialmicrobiocidal effects of the cleaning processes and solutions.This method examines the reduction inthe number of spores as a tracer of foreign materials and not necessarily the reduction in organic soildirectly.This test may be designed to either examine the efficacy of a complete cleaning cycle consisting ofseveral integrated steps or individual cleaning step such as precleaning,manual cleaning,automatedcleaning or rinsing.1.Scope1.1 This test method is written principally for large medicalinstruments or instruments with internal channels or recesses(for example,flexible endoscopes)but may be used for anyresuable medical instruments.1.2 This test method describes a procedure for testing theefficacy of a cleaning process for reusable medical instrumentsartificially contaminated with mixtures of microorganisms andsimulated soil.1.3 The test method utilizes bacterial spores as tracers forforeign materials and quantifies their removal as a means ofdetermining the efficacy of a cleaning process.1.4 The test method is designed for use by manufacturers ofmedical instruments and devices.However,it may also beemployed by other individuals who have a knowledge of theinstruments,techniques and access to appropriate facilities.1.5 Worst-case conditions can be represented by exaggerat-ing a specific test parameter or otherwise intentionally simu-lating an extreme condition such as performing the test withoutcleaning solutions or utilizing instruments which are not new.1.6 The test procedure is devised to determine the efficacyof a cleaning process as applied to a particular instrument orgroup of instruments by simulating actual use situations.1.7 The test procedure may be performed on test instru-ments using a complete cleaning cycle or be limited to1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agentsand is the direct respon-sibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved Oct.1,2014.Published December 2014.Originallyapproved in 2003.Last previous edition approved in 2008 as E2314 03(2008).DOI:10.1520/E2314-03R14.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 particular phases of the cycle such as precleaning,manualcleaning,automated cleaning,or rinsing.1.8 The test procedure is normally performed on a numberof external and internal sites,but it may be restricted to oneparticular site on the instrument.1.9 A knowledge of microbiological and aseptic techniquesand familiarity with the instruments is required to conductthese procedures.NOTE1Because contamination of the surfaces of instruments mayoccur as a result of rinsing with tap water,bacteria-free water should beused for all rinsing when a water rinse step is part of the cleaningdirections.NOTE2Test methods to determine the effectiveness of cleaningmedical instruments has only recently been actively debated,and researchefforts are in their infancy.Because p