ASTM_E_1766_-_15.pdf

Designation:E176615Standard Test Method forDetermination of Effectiveness of Sterilization Processes forReusable Medical Devices1This standard is issued under the fixed designation E1766;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.1.Scope1.1 This test method covers a reproducible procedure fortesting processes used to sterilize reusable medical devices(instruments).This test method is not designed to validate asterilization process,but tests an established sterilization cycleor process.It is a practical test of the effectiveness of asterilization process applied to reusable medical devices.Bac-terial spores more resistant to the test sterilant than the naturalbioburden of the instrument are used as the test organisms.Commercially available liquid suspensions of bacterial sporesare used to inoculate the instruments.1.2 This test method is intended for reusable medicaldevices cleaned in accordance with the device manufacturersinstructions and prepared for sterilization in accordance withthe instructions for the sterilization process being used.1.3 This test method assumes that cleaned,reusable medicaldevices will be free of visible soil but may have remainingadherent bioburden.Aworst-case bioburden can be representedby suspensions of bacterial endospores,which are commer-cially available for monitoring chemical or physical steriliza-tion processes.These endospores should have a verifiableresistance(D value)to the specific process and sterilant beingevaluated.21.4 It is impractical to test for the sterility of some devicesby immersion in growth medium because of their complexity,size,and availability(for long-term incubation)or adverseeffects on the devices from long-term immersion.Therefore,elution,rinsing,or swabbing techniques are used to recover testorganisms from inoculated devices.1.5 A recovery control will be included by inoculation of atest device and use of the elution methods without applying thesterilization process being tested.A minimal recovery of 106colony-forming unit(CFU)/mL per device is required for therecovery control.1.6 Results of the recovery control and process test cycle arecompared to determine the effectiveness of the sterilizationprocess.1.7 Results of the recovery control and applied inoculum arecompared to determine the recovery efficiency,if desired.1.8 The procedure should reveal that tested devices are freeof recoverable microorganisms when five or more consecutivetests are conducted.1.9 A knowledge of microbiological techniques is requiredto conduct these procedures.1.10 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.11 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:3D1193 Specification for Reagent WaterE1054 Test Methods for Evaluation of Inactivators of Anti-microbial Agents2.2 Other:ASTM Poster Presentation:“Use Verification of a ProposedDraft ASTM Standard to Determine the Efficacy ofSterilization Techniques for Reusable Medical Instru-ments”Presented at the E35.15 Subcommittee meeting inMontreal,Canada3.Terminology3.1 Definitions:1This test method is under the jurisdiction of ASTM Committee E35 onPesticides,Antimicrobials,and Alternative Control Agents and is the directresponsibility of Subcommittee E35.15 on Antimicrobial Agents.Current edition approved May 1,2015.Published December 2015.Originallyapproved in 1995.Last previous edition approved in 2007 as E1766 95(2007).DOI:10.1520/E1766-15.2Oxborrow,G.S.,and Berube,R.,“Sterility TestingValidation of SterilizationProcesses,and Sporicide Testing,”Disinfection,Sterilization,and Preservation,Block,S.S.,4th Edition,Lea and Febiger,Philadelphia,PA,1991,pp.10471058.3For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.1 bioburdenthe number and types of viable microor-ganisms that contaminate a device.3.1.2 CFUcolony-forming unit.3.1.3 inoculumthe number(usually specified as CFUs)and type(genus and species)of viable microorganisms used tocontaminate a given sample or device.3.1.4 sporicidal agentany chemical or physical agent thatkills spores.3.1.5 sterilantany sterilizing agent.3.1.6 sterilea state of being free of living organisms.3.1.7 sterilization cy