Technical Information Report
Designing testing andlabelingreusablemedicaldevicesforreprocessinginhealthcarefacilities:A guideformedicaldevicemanufacturers
Associationfor theAdvancementof Medical Instrumentation
Designing testing andlabelingreusablemedical devicesforreprocessinginhealthcarefacilities: Aguideformedicaldevicemanufacturers
Approved7 September 2010
Association for the Advancement of Medical Instrumentation
Abstract:
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to helpensure that their products canbe safely andeffectivelyreprocessedltalsoprovidesinfomationondecontaminationcleaning disinfction andsterlizationprocessesmonlyusedinhealthcarefacitiessothatmanufacturers canhealthcaefleabngecmndosandimtonalcalerglaons yalidatereprocessing procedures that can beremended toandperformedadequatelyinalso provided in the TiR as wellas a bibliography and othernfomative annexe.
Keywords:
cleaning decontamination disinfection instructions foruse medical device dosign sterlization
Contents
AAMI Technical Information Report
Atechnical information report (TIR)isapublcationof the Association for the Advancement of Medical pep odseeed essspeeegseps()
Glossary of equivalent standards.Committe representatio... viForeword. XIntroduction- .111.1 Inclusions. .1 .12Definitions and abbreviations.. 1.2 Exclusions.. .2.23 3.1 Overvie. Design considerations. .53.2Categoriesofmedicaldevices 33Physicaldesignonsiderations .53.4Materialdesignconsiderations. 3.4.1 General considerations. 6 F3.4.2 3.4.3 Polymeric materials Metals....3.5 Total system design considerations. 3.6 Misuse-related design considerations.. 8'3.7 Device equvalence.... 3.7.1 Generalconsierations. 6 6”3.7.3 3.7.2 Masterproducts. Product families .9 6” 63.8Product functionalit.. 3.7.4 Equivalence assessment. 10 103.8.2 3.8.1 General considerstion.. Determination of functionality.. 10 103.8.3 Maintenance and documentation of functionality... 10Decontamination... 4.1 Overview.. 11 114.2 Commonhospitalcleaning/decontamination agentsand procedures 4.2.1 General consideration.. 11 114.2.3 4.2.2 Disassemblyandsoring.. Precleaningatthe point of use.. 124.2.4 4.2.5 Cleaningnsngandrssbl. Cleaning methods and equipmen.. 12 12 154.3Manufacturersresponsibiie.. 4.3.1 General considerations.. 18 184.3.2 4.3.3 Waterqualty forcleaning.. Cleaningagents. 19 194.3.4 4.3.5 Cleaningprocedures. Test data and userverication... 19Disinfection with liquid chemicals . 20 215.2Levels of disinfectantactivity 5.1 Overview.... 215.2.2 5.2.1 High-level disinfection. General considerations. 21 215.23 Intermedlate-level disinfection . 22 245.2.4 Low-level disinfection. 24
AthoughthemateriapresentedinaTIRmayeedfutherevalutionbyxpertsrelaingtheinfomationvaluablepeuesdunune
ATIR differs markedly from a standard or remended practice and readers should understand the differences between these documents.
Standardandrcmndprtasutfmresmieapprovalblrd resolutionflmmentshisrocssfcnsensusssuevisedbytheMStandardsoardandinthecasfAmerican National Standards by the American National Standards Institute.
ATRstamfmlrcstnawsrdrisbnby a technical mittee and the AAMi Standards Board.
Anotherdiference isthat athoughboth standardsandTIRsare periodicallyrevieweda standard mustbe acted onreafmieinttnfleualyyar ForaTRAAMlconsultswithalechnicalmitteeaboutfiveyearsafterthepublicationdate（andperiodicallythereafterforguidanceonwhthertedcumentisstilusefulhatistocheckthattheinformationsrelevantorf historical value. If the information is not useful the TIR is removed from circulation.
ATIRmyedevlodbcaueiimrrepnetnderingftyrefmaneesthntadarrremendedpracticerecauseachevingconsensussexremelydifioultrnlkelyikeastandardi permits the inclusion of differing viewpoints on technical ssues.
CAUTIONNOTICE:ThisAAMTIRmayberevisedorwithrawnatanytimeBecauseitaddressesarapidlyevolvingfield of technology readers are cautioned to ensure that they have also considered information thatmay be more recent than this document.
Allstandardsremendedpracticestechnicalinfmationreportsandothertypesftechnicaldocuments developedbyAMaeluntaryndthapliationisolelywthinthdisretinandprfessionuentftuserofthedocuentOasionllyvluntarytechnicaldocumentsardoptedbygoveentregulatoryageniessuoenbo
Comments on this technical informationreporare invitedand should be sent to AAMIAttn:Standards Department 4301N.Fairfax Dr Suite301 Arlington VA 22203-1633.
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@ 2010 by the Association for the Advancement of Medical Instrumentation
All Rights Reserved
Publislf documentwithoutthepriorwritenermissionoftheAssociationfortheAdvancementofMedicallnstrumentationsthisdcuenththerinllyreemlywithoutthprorwrtenemsnfthssocionfot strictlyprohibtedbyaw.ltisgal underfederallaw17.S.C.101tq.）tomakeopiesfalloranyparfAdvancementofModical Instrumentation.Violatorsrisk legalaction Includingciviland criminal penalties and damagefrffeFrmisinegardintfallranfthisunmreprinteqestformatwamrgrontactMIt30.FaifaxriveSui01ArintonVA3Phone: (703) 525-4890; Fax: (703)525-1067.
Printed in the United States of America
ISBN 1570203970
Annexes
Tables
5.3Deviceesignsideratinsfrdisinftionwithlquidchical 25 255.5Toxiclty 26 265.6Materialis paibilit. 5.7Eficacyoftheproces.. 26 265.8 Test data and user verification..
6.2Sterlionprocessesavallableforusnhealcarefliie 6.1Overview.. 27 276.3 Device designconsiderations for sterlization.. 28 296.6Deveandstezationooailt 6.5 Sterilizationefficacy testing..i 29 316.7 Evaluationofsterilantresidues and aerationorrinsingparameters. 32 326.7.1 6.7.2 General considerations... Ethyleneoxide.... 32 326.7.3 6.7.4 Other sterilant residues Rinsing parameters... 32 326.8Documentationofqualfication. 34 336.9.1 Lumened devices ..
A Liquidchemicaldisinfectantsmonlyusedinhealthcarefacities 35B c ProceingJ-coninatedpatietcarequipmentandevironmntalurfac Steriizationcyclesmonlyavailable inhealthcarefacities.. 37 43D E Regulaoryconsideration... Bibliography. 49 44
1 Types of enzymes used in enzymatic detergents.. Microorganismslistedindescendingorderofresistance tochemical sterilants anddisinfoctants. 14 232 3 24B.1Time and temperature parameters for gravitydisplacement steam sterlization cycles in health care 4 products.... 2437B.3Depthandnumberof vacuumpulsesremendedfortheBowie-Dicktest faclities.... 86 39B.5Parametersfordryhatserzatoncyclesinhathcarefaie.. B.4ParametersforEOsteriizationcyclesinhealthcarefacilitie 40 40B6Examplesofparametersforiquidchemicalsterilatcycle B.7Parametesforhyrogenperxideseriztioncclesnalhcarefali 41 41B8Parmersforhydrgnperxideasstizatoncylsinthcarefl B.9 Parameters for chemical vaporsterilization cycles in health care faclities.. 42 42B.10Parametersforzone sterizationcclsinhealthcarefiities. 42
Glossary ofequivalent standards
nproductionasof13October2010
Standards.ForeachIntemational Standard thathas beenadopted byAAMI(and ANSl）thetablebelowgivesthe IntermationalStandardsadopted in theUnitedStatesmay include normativereferences toother Intemationalcorresponding US.designationand level of equivalency to thentematlonalStandard.NOTE:Documents aresorted by international designation.The codein the US column (R)20xxindicates the year the document was officiallypublshed in 2002 was reaffrmed without change in 2009.
therefore this list should not be considered exhaustive.
Intemational designation U.S.designationIEC60601-1:2005 ANSI/AAMI ES60601-1:2005and ANSI/AAMlMajortechnical variations EquivalencyTechnical Corrigendum 1 and 2 ANSIAAMIES60601-1:2005/C1:2009(amdtC1dentical toCorigendum1&2 ES60601-1:2005/A2:2010IEC60601-1-2-2007 ANSI/AAMI/IEC60601-1-2:2007 ANSI/AAM/IEC60601-2-2:2009 Identical IdenticalIEC 60601-2-19:2009 IEC 60601-2-4:2002 ANSI/AAM/IEC60601-2-19:2009 ANSI/AAMIDF80:2003/(R)2010 Major technical variations denticalIEC60601-2-20:2009 IEC60601-2-21:2009 ANSU/AAM/IEC 60601-2-20:2009 ANSVAAM/IEC60601-2-21:2009 Identical IdenticalIEC60601-2-24:1998 IEC60601-2-47:2001 ANSI/AAMIID26:2004/(R)2009 ANSI/AAMIEC38:2007 Major technical vanations Major technicalvariationsIEC80001-1:20xx IEC60601-2-50:2009 ANSI/AAMI/EC80001-1:2010 ANSI/AAMIIEC60601-2-50:2009 Identical IdonticalIEC 80601-2-30:2009 and Technical Corrigendum1 ANSI/AAM/IEC80601-2-30:2009and ANSI/AAMI/IEC80601-2-30:2009/C1:2009 Identical (with inclusion)EC/TR60878:2009 IEC80601-2-58:2008 ANSI/AAM/IEC80601-2-58:2008 (amdt)-consolidated text IdenticalEC/TR622962009 ANSI/AAM/IECTIR60878:2003 ANSWAAMIECTIR62296:2009 Identical IdenticalIEC/TR62348:2006 IEC62304:2006 ANSI/AAM/IEC62304:2006 ANSVAAMMIECTIR62348:2006 Identical IdenticalIEC/TR62354:2009 ANSI/IEC/TR80002-1:2009 ANSI/AAMI/IECTIR62354:2009 Identical IdenticalISO5840:2005 ISO7198:1998 ANSW/AAMI/SO7198:1998/2001/(R)2010 ANSI/AAMI/SO5840:2005/(R)2010 IdenticalISO86372010 ISO7199:2009 ANSI/AAMI/ISO B637:2010 ANSI/AAMI/ISO7199:2009 Identical IdenticalISO8638:2010 ISO10993-1:2009 ANSIWAAM/ISO8638:2010 ANSI/AAM/ISO10993-1:2009 Identical IdenticalISO10993-2:2006 ANSI/AAMI/ISO 10993-3:2003/(R)2009 ANSIAAMI/ISO 10993-2:2006 Identical identicalAmendment 1:2006 ANSI/AAMI/ISO10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 IdenticalISO10993-5:2009 ISO10993-6:2007 ANSI/AAMI/ISO10993-5:2009 ANSI/AAMI/ISO10993-6:2007 Identical IdenticalISO10993-72008 ISO10993-9:2009 ANSI/AAM/ISO10993-72008 ANSI/AAMI/ISO 10993-9:2009 IdenticalISO 10993-10:2010 ISO10993-11:2006 ANSI/AAMI/SO10993-11:2006 ANSI/AAMI/ISO10993-10:2010 Identical ldenticalISO10993-12:2007 ISO 10993-13:2010 ANSI/AAM/ISO10993-13:20xx Identical IdenticalISO 10993-14:2001 ISO 10993-15:2000 ANSI/AAMU/SO10993-15:2000/(R)2006 ANSI/AAM/SO10993-14:2001/(R)2006 Identical IdenticalISO10993-17:2002 ISO10993-16:2010 ANSIAAM/SO10993-17:2002/R)2008 ANSI/AAMI/ISO10993-16:2010 Identical IdenticalISO10993-18:2005 ANSI/AAMIBE83:2006 Major technical variations
International designation U.S.designation EquivalencyISO/TS10993-19:2006 ISO/TS10993-20:2006 ANSI/AAMI/SOTIR10993-202006 ANSI/AAMI/ISOTIR10993-19:2006 Identical IdenticalISO11135-1:2007 ISO/TS11135-2:2008 ANSWAAM/SOTIR11135-2:2008 Identical IdenticalISO11137-12006 ISO 11137-22006(2006-08-01 ANSUAAM/ISO 11137-1:2006/(R)2010 ANSI/AAM/ISO11137-2:2006 Identical Identicalcorrected version) ISO11137-3:2006 ANSU/AAM/SO 11137-3:2006/(R)2010 IdenticalISO11138-1:2006 ISO 11138-2:2006 ANS/AAMI/SO11138-1:2006/(R)2010 ANSUAAMI/SO11138-2:2006/(R)2010 Identical IdenticalISO 11138-3:2006 ISO 11138-4:2006 ANSU/AAMI/SO11138-3:2006/(R)2010 ANSUAAM/SO11138-4:2006/(R)2010 Identical IdenticalISO 11138-5:2006 ISO/TS11139:2006 ANSI/AAMMSO11138-5:2006/(R)2010 Identical IdenticalISO11140-1:2005 ANSIAAM/SO11140-12005/(R]2010 ANSI/AAM/ISO11140-3:2007 Identical IdenticalISO11140-5:2007 ANSI/AAM/SO11140-4:2007 ANSI/AAM/SO11140-5:2007 Identical IdenticalISO11607-1:2006 ANSI/AAMI/ISO11607-22006 Identical IdenticalISO11737-1:2006 ANSI/AAM/ISO11737-12006 ANSI/AAM/SO11737-22009 Identical IdenticalISO11737-2-2009 Identical IdenticalISO13408-3:2006 ISO13408-2:2003 Identical IdenticalISO13408-5:2006 ANSV/AAMISO13408-62008 Identical denticalSO14155-12003 ISO13485:2003 ISO13408-6:2006 ANSI/AAMI/SO134852003/(R)2009 ANSI/AAM/ISO14155-12003/(R)2008 Identical IdenticalISO 14155-2:2003 ANSI/AAMMSO14155-22003/R)2008 ANS/AAMI/ISO14160:1998/(R)2008 Identical IdenticalISO14708-3:2008 ISO 14160:1998 ISO14161:2009 ANSI/AAMI/ISO14161:2009 ANSI/AAMI/ISO14708-3:2008 Identical IdenticalISO 14708-4:2008 ANSI/AAMI/SO14708-4:2008 ANSUAAMI/ISO14708-5:2010 Identical IdenticalISO/TR149692004 ISO 14708-5:2010 ISO14937:2009 ANSUAAM/ISO149372009 ANSI/AAM/ISOTIR14969:2004 Identical IdenticaliSO15223-12007and A1:2008 ANSI/AAM/ISO14971:2007(R)2010 ANSI/AAM/ISO15223-1:2007andA1:2008 Identical IdenticalISO15223-2:2010 ANSI/AMU/ISO15223-2:2010 ANSI/AAM/SO15225:2010 Identical IdenticalISO15225:2010 Identical IdenticalISO15882:2008 ANSU/AAMIST15883-1:2009 Major technical variations IdenticalISO/TR16142:2006 ISO15883-1:2006 ANSI/AAMISOTIR16142:2005 ANSI/AAMIST812004 IdenticalISO17664:2004 ISO17665-1:2006 ANSI/AAM/ISO17665-1:2006 ANSI/AAMI/SOTIR17665-22009 identical(withindlusions) IdenticalISO/TS 17665-2:2009 ISO18472:2006 ANSI/AAM/SO19218:2005 Identical IdenticalISO/TS19218:2005 ISO22442-12007 ANSI/AAM/SO22442-12007 Identical IdenticalISO22442-3:2007 ANSI/AAMI/SO25539-1:2003/(R)2009 and IdenticalISO 25539-1:2003 and A1:2005 ANSI/AAMMSO25539-22008 A1:2005/(R)2009 Identical IdenticalISO 27186:2010 ISO25539-22008 ANSI/AAM/ISO81060-1:2007 Identical identicalISO81060-2:2009 ISO81060-1:2007 ANSI/AAM/ISO81060-2:2009 Identical
Committeerepresentation
Instructions for Reusable Device Reprocessing Working Group Association for the Advancement of Medical Instrumentation
WorkingGroup underthe ausplces of the AAMiSterizationStandards Committee.Approval of the TIR doesnotnecessarilymean that all working groupmembers voted forits approval.
At the ime this document was publshed the AAMI Instructions for Reusable Device Reprocessing Working
Cochairs: RalphJBasile MBAHalthmark IndCo Inc.Members: Nancy Chobin RN CSPDM Independent ExpertBrian C. Brosdahl PhD Sterlucent Inc. ReneeCamp EthoxinteationalInc BradleyJCatalonePhDOlymusAmericanc.NancyChobinNCPDMndendenEMicheleDawnDemeoCRCSTCSPDT IndependentExpet AnthonyJ.DeMarinisBSMSCQACQMCRBard JacquelineDaiey IndependentExperBettyD.EdgeInedntxSueEllenEricksonMSCNORIndependentExper RosieFardoRNBSNCICCHSPDparmentof teransAffairsMedicalCetrThomas J.FrazarJohnson&Jahnson Susan Flnn3MHalthareFranceFrochetMScTSOIn. VeranicaGileauAlconLaboratories Ing.ZoryR.GlaserPhDMPHCSPOMndependentExpt SteveN.GodstinePhDIndndentExpDougF.HbrehtBostonScnticCoportn Rachel Hil CareFusionBrent HubertySt Jude Medical Inc.StephenMKovachHealthmarkndCon Susan GKlacikCCSMCFCSACEAHCSMM RolandC.KippenhanMinnechCorporationColleenPatricLnderNCanadanStandardsscitin TecklaAMarescaLPNCSPMIndependentExpertRussel D.Mils Zimmer lnc. PatrickJ.McComickPhD Baush&Lomb Inc.EmilyMitzeMSNelsnLaboratoriesnc RichardTODonnelSterisCorporationDave Parente NAMSARose E.Seavey，RN MBACNOR CRCST Independent Expert Rodney D.Parker Stryker Instruments Division VanaPoovalaPhllsHealtcreLindaSoneRNSPANORndpendenExDonaldTummineliSPSMedicaSupplyCop JoanM.Spear Aesculap Inc.Nora E.Wikander RN CSPDM Independent Expert ChristieHYunkerbott Laboratrs Steven E.Turtl FDA/CDRHAltemates: Denise Adams Aesculap Inc. SusanneAndersonNAMSAEdwardArscottJohnson&Johnson David E.Barlow PhD Olympus America Inc.RalphJBaslle MBAHealthmark Ind Co Inc. Carlos ChavezPhDAbbotLaboratoriesCharles Cogdil Boston Scientific Corporation
