AAMIST79-2017衛(wèi)生保健設(shè)施蒸汽滅菌和無(wú)菌保證綜合指南

AAM『

AdvancingSafetyinHealthcareTechHOJogy

ANSIAAMIST79-2017

Comprehensiveguidetosteam

sterilizationandsterilityassurancein

healthcarefacilities

American

NationalStandard

ObjectivesandusesofAAMI

standardsandrecommended

practices

IlisnlostimportantthattheobjectivesandpotentialusesofanEachAAMIstandardorrecoinInendedpracticereflectsthe

AAMIproductstandardorrecommendedpracticeareclearlycollectiveexpertiseofacommitteeofheahhcareprofessionalsand

understood.TheobjectivesofAAMI'stechnicaldevelopmentindustrialrepresentatives,,vhose,vorkhasbeenreviewed

progran1derivefronlAAMI'soverallInission:(headvance!nenlofnationally(andson1etinlesintemationally).Assuch,theconsensus

medicalinstrumentation.Essentialtosuchadvancementare(1)arecommendationsembodiedinastandaidorrecommendedpracticeare

continuedincreaseinthesafeandeffectiveapplicationofcurrentintendedtorespondtoclinicalneedsand,ultinlately.tohelp

techoologiestopatientcare,and(2)theencounIgementofnewensurepatientsafety.AstandardorrecoinInendedpracticeis

technologies.ItisAAlMl'sviewthatstandiirdsandrecommendedlilniied.however,in(hesense(hatitrespondsgenerallyto

practicescancontributesignificantlytotheadvancementofperceivedrisksandconditionsthatmaynotalwaysberelevantto

medicalinstrunIentation,providedthattheyaredraftedwithspecificsituations.Astandardorrecotn111endedpracticeisan

attentiontotheseobjectivesandprovidedthatarbitraryandiniportantreferenceinresponsibledecision-nlaking,butilshould

restrictiveusesareavoided.neverreplaceresponsibledecision-making.

AvoluntarystandardfbranledicaldevicerecommendstotheDespiteperiodicreviewandrevision(atleastonceeveryfive

nIanufacturertheinfonnationthatshouldbeprovidedwithoronyears),astandardorrecon1n1endedpracticeisnecessarilyastatic

theproduct,basicsafetyandperformancecriteriathatshouldbedocumentappliedtoadynamictechnology.Therefore,astandards

consideredinqualifyingthedevicefbrclinicaluse,andtheusermustcarefullyreviewthereasonswhythedocumentwasin

measurenlenitechniquesthatcaobeusedtodeterminewhethertheitiallydevelopedandthespecificrationalefbreachofits

deviceconfonuswiththesafetyandperfolmancecriteriaand/ortoprovisions.Thisreviewwillreveal,vhetherthedocumentremains

comparetheperformancecharacteristicsofdifferentproducts.relevanttothespecificneedsoftheuser.

Somestandardseinphasize(heiofbnnationthaishouldbeprovidedParticularcareshouldbetakeninapplyingaproductstandard(o

withthedevice,includingperformancecharacteristics,instructionsforexistingdevicesandequipnlent,andinapplyingarecomn1ended

use.warningsandprecautions,andotherdataconsideredpracticetocurrentproceduresandpractices.Whfleobservedor

importantinensuringthesafeandeffectiveuseofdiedeviceintheclinpotentialrisksWithexistingequipmenttypicallyIbrmthebasisfbr

icalenvironment.Recomnlendingthedisclosureofthesafetyandperfbmlancecriteriadefinedinastandard,

performancecharacteristicsoftennecessitatesthedevelopmentofprofessionaIjudgmentmustbeusedinapplyingthesecriteriato

specializedlestmethodstofacilitateuniformityinreporting;existingequipment.Nosinglesourceofinformationwillserveto

reachingconsensusonthesetestscanrepresentaconsiderablepanofidentifyaparticularproductas"unsafe".Avoluntarystandardcan

conunitteework.Whenadraftingcommitteedeiernlines(hatbeusedasoneresource,buttheuItimatedecisionastopnxluct

clinicalconcernswarranttheestablishmentofIni11iniunisafetysafetyandefficacymusttakeintoaccountthespecificsofitsuti

andperformancecriteria,refereetestslnus<beprovidedandthelizationand,ofcourse,cost-benefitconsiderations.Similarly,a

reasonsforestablishingthecriteriamustbedocunlentcdintherecom,nendedpracticeshouldbeanalyzedinthecontextofthe

rationale.specificneedsandresourcesoftheindividualinstitutionorfinn.

AreconIntendedpracticeprovidesguidelinesfbrtheuse.care,Again,therationaleaccompanyingeachAAMIstandardand

and/orprocessingofamedicaldeviceorsysteln.Arecotrunendedrecomn1endedpracticeisanexcellentguidetothereasoningand

practicedoesnotaddressdeviceperformanceperse,butratherdataunderlyingitsprovision.

proceduresandpracticesthatwillhelpensurethatadeviceisusedInsurrunary.astandardorrecommendedpracticeistruly

safelyandeffectivelyand(HatitsperfonnancewillbeInaintained.usefulonly,.vhenitisusedinconjunctionwithothersourcesof

Althoughadevicestandardisprinlarilydirectedtothemanuinformationandpolicyguidanceandinthecontextofprofessional

facturer.itmayalsobeofvalueiothepotentialpurchaseroruseroftheexpeiienceandjudgmenl.

deviceasaframeofreferencefbrdeviceevaluation.Similarly,even

d1ougharecon1n1endedpracticeisusualJyorientedtowardsINTERPRETATIONSOFAAMI

healthcareprofessionals,itmaybeusefultothemanufacturerinSTANDARDSAND

betterunderstandingtheenvironmentinwhichamedicaldevicewillRECOMMENDEDPRACTICES

beused.Also,somerecommendedpractices,

,vhilenotaddressingdeviceperfonnancecriteria,provideRequestsforinterpretationsofAAMIstandardsandrecommended

guidelinestoindustrialpersonnelonsuchsubjectsassterilizationpracticesmustbemadeinWriting,totheAAfVlIVicePresident.

processing,metllodsofcollectingdatatoestablishsafetyandStandardsPolicyandProgranIs.AnofficialinterpretalionInustbe

efficacy,hunlanengineering,andotherprocessingorevaluationapprovedbyletterballotoftheoriginatingcommitteeand

techniques;suchguidelinesmaybeusefultohealthsubsequentlyreviewedandapprovedbytheAAMIStandards

careprofessionalsinunderstandingindustrialpractices.Board.Theinterpretation.viiibecomeofficialandrepresentationof

IndeterriIiJlingwhetheranAAMIstandardorrecon1111endedtheAssociationonlyuponexhaustionofanyappealsandupon

practiceisrelevant(othespecificneedsofapotentia1userofthepublicationornoticeofinterpretationinrhe"StandardsMonitor"

document,severalimportantconceptsmustberecognized:sectionoftheAAMINews.TheAssociationfortheAdvancc.nenl

AllAAl'vllstandiirdsandrecommendedpracticesarevoluntaryofMedicalInstru!1lentationdisdainIsresponsibiJjtyfbrany

(unless,ofcourse,theyareadoptedbygovernn1entregulatoryorcharacterizationorexplanationofastandardorrecommended

procurer!Ientauthorities).TheapplicationofastandardorpracticeWhichhasnotbeendevelopedandcommunicatedin

recolnnlendedpracticeissolely,vithi.nthediscretionandaccordancewiththisprocedureandwhichisnotpublished,by

professionaljudgmentoftheuserofthedocument.appropriatenotice,asanofficialintelpretationintheAAMINelvs.

AmericanNationalStandardANSI/AAMIST79:2017

(RevisionofANSI/AAMIST79:2010/(R)2014&A1:2010&A2:2011&A3:2012&A4:2013)

Comprehensiveguidetosteamsterilizationand

sterilityassuranceinhealthcarefacilities

Abstract：Thisrecommendedpracticecoverssteamsterilizationinhealthcarefacilities.The

recommendationsareintendedtopromotesterilityassuranceandtoguidehealthcarepersonnelin

theproperuseofprocessingequipment.Includedwithinthescopeoftherecommended

practicearefunctionalandphysicaldesigncriteriaforsterilizationprocessingareas

(decontamination,preparation,sterilization,andsterilestorageareas);staffqualifications,

education,andotherpersonnelconsiderations;processingprocedures;installation,care,and

maintenanceofsteamsterilizers:qualitycontrol;andqualityprocessimprovement.

Keywords：ambulatorycarefacilities,cleaning,continuousqualityimprovement,decontamination,dentaloffice,

immediate-usesteamsterilization(IUSS),moistheatsterilization,packaging,qualitycontrol,

qualitysystem,saturatedsteam,sterilestorage,sterilizationcontainers,surgicalinstruments,

table-topsterilizers

AAMI

Singleuserlicense.Furthercopying,networking,anddistributionprohibited.

AAMIRecommendedpractice

ThisAssociationfortheAdvancementofMedicalInstrumentation(AAMI)recommendedpracticeimpliesaconsensusofthose

substantiallyconcernedwithitsscopeandprovisions.TheexistenceofanAAMIrecommendedpracticedoesnotinany

respectprecludeanyone,whethertheyhaveapprovedtherecommendedpracticeornot,frommanufacturing,marketing,

purchasing,orusingproducts,processes,orproceduresnotconformingtotherecommendedpractice.AAMI

recommendedpracticesaresubjecttoperiodicreview,andusersarecautionedtoobtainthelatesteditions.

CAUTIONNOTICE:ThisAAMIrecommendedpracticemayberevisedorwithdrawnatanytime.AAMIproceduresrequirethat

actionbetakentoreaffirm,revise,orwithdrawthisrecommendedpracticenolaterthanfiveyearsfromthedateofpublication.

InterestedpartiescanobtaincurrentinformationonallAAMIdocumentsbycallingorwritingAAMl.

AllAAMIstandards,recommendedpractices,technicalinformationreports,andothertypesoftechnicaldocumentsdeveloped

byAAMIarevoluntary,andtheirapplicationissolelywithinthediscretionandprofessionaljudgmentoftheuserofthe

document.Occasionally,voluntarytechnicaldocumentsareadoptedbygovernmentregulatoryagenciesorprocurement

authorities,inwhichcasetheadoptingagencyisresponsibleforenforcementofitsrulesandregulations.

Publishedby

AAMI

4301N.FairfaxDr.,Suite301

Arlington.VA22203-1633

?2017bytheAssociationfortheAdvancementofMedicalInstrumentationAll

RightsReserved

Publication,reproduction,photocopying,storage,ortransmission,electronicallyorotherwise,ofalloranypartofthis

documentwithoutthepriorwrittenpermissionoftheAssociationfortheAdvancementofMedicalInstrumentationisstrictly

prohibitedbylaw.Itisillegalunderfederallaw(17U.S.C.§101,etseq.)tomakecopiesofalloranypartofthisdocument

(whetherinternallyorexternally)withoutthepriorwrittenpermissionoftheAssociationfortheAdvancementof

MedicalInstrumentation.Violatorsrisklegalaction,includingcivilandcriminalpenalties,and

damagesof$100,000peroffense.Forpermissionregardingtheuseofalloranypartofthisdocument,completethereprint

requestformatorcontactAAMI,4301N.FairfaxDr.,Suite301,Arlington,VA22203-1633.Phone:+1-703-525-

4890;Fax:+1-703-525-1067.

WiththepermissionofCanadianStandardsAssociation,(operatingasCSAGroup),materialisreproducedfromCSAGroup

standard2314.8-00,DecontaminationofreusablemedicaldeviceswhichiscopyrightedbyCanadianStandards

Association,178RexdaleBlvd.,Toronto,ON.M9W1R3.ThismaterialisnotthecompleteandofficialpositionofCSA

Grouponthereferencedsubject,whichisrepresentedsolelybythestandardinitsentirety.Whileuseofthematerialhasbeen

authorized,CSAGroupisnotresponsibleforthemannerinwhichthedataispresented,norforanyinterpretationsthereof.

Nofurtherreproductionispermitted.FormoreinformationortopurchasestandardsfromCSAGrouppleasevisit

http://shop.csa.ca/orcall1-800-463-6727.

PrintedintheUnitedStatesofAmerica

ISBN978-1-57020-675-7

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ContentsPage

Glossaryofequivalentstandardsix

Committeerepresentationxii

Forewordxv

Introduction:Needfortherecommendedpractice1

1Scope3

1.1General3

1.2Inclusions3

1.3Exclusions3

2Definitionsandabbreviations4

3Designconsiderations12

3.1Generalconsiderations12

3.2Workareadesignandfunctionalworkflow12

3.2.1Designcriteria12

3.2.2Functionalworkflowpatterns14

3.2.3Trafficcontrol15

3.3Utilities17

3.3.1Mechanicalsystems17

3.3.2Electricalsystems17

3.3.3Steamforsterileprocessing17

3.3.4Utilitymonitoringandalarmsystems18

3.3.5Generalfacilitydesignrequirements18

3.3.6Specialarearequirementsandrestrictions21

3.3.7Emergencyeyewash/showerequipment24

4Personnelconsiderations25

4.1Generalconsiderations25

4.2Qualifications25

4.2.1Supervisorypersonnel25

4.2.2Sterileprocessingpersonnel25

4.3Educationandtraining26

4.3.1Sterileprocessingpersonnel26

4.3.2Servicepersonnel26

4.3.3Otherpersonnel27

4.4Healthandpersonalhygiene27

4.5Attire27

4.5.1Generalconsiderations27

4.5.2Decontaminationarea/room28

4.6Standardandtransmission-basedprecautions29

5Receiving30

5.1Generalconsiderations30

5.2Receivingofpurchasedorloaneditems30

5.2.1Generalconsiderations30

5.2.2New,repaired,andrefurbishedreusableitems30

5.2.3Loanedorborrowedinstrumentation30

5.2.4Rigidsterilizationcontainersystems31

5.2.5Disposableitems32

5.3Dispositionofsterileitems(issuedbutnotused)32

6Handling,collection,andtransportofcontaminateditems33

6.1Generalconsiderations33

6.2Separationofwasteandreusableitemsatpointofuse33

6.3Point-of-usecareandhandlingofcontaminatedreusableitems34

6.4Containment35

6.5Transport36

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36

6.5.1Segregationofclean/sterileitems二36

6.5.2Transportationschedulingandroutes36

6.5.3Transportationequipment336

6.5.4Handtransport：

：37

6.5.5Dedicatedlifts37

6.5.6Transportbetweenbuildings二37

6.5.7Off-sitetransportation

7Cleaning.dismfection(microbicidalprocesses),andotherdecontaminationsteps39

7.1Generalconsiderations39

7.2Policiesandprocedures39

7.3Manufacturer'swrittenIFU40

7.4Decontamination40

7.4.1Generalconsiderationsforalldevicesandutensils40

7.4.2Specialconsiderations41

7.5Preparationforcleaning41

7.5.1Presoaking41

7.5.2Sortinganddisassembly41

7.6Cleaning43

7.6.1Generalconsiderations43

7.6.2Deviceswithlumens44

7.6.3Cleaningagents.44

7.6.4Methodsofcleaning44

8Preparationandassemblyofinstruments50

8.1Generalconsiderations50

8.2Instruments50

8.3Deviceswithlumens51

8.4Basinsandbasinsets51

8.5Textilepacks51

9Packaging52

9.1Generalconsiderations女

9.2Selectionofsterilebarriersystems

9.3Packagelabeling

...52

9.4Packageclosures...S3

9.5Sterilizationwrap

...噴53

9.5.1Generalconsiderations

9.5.2Wovenwraps

9.5.3Nonwovenwraps

9.5.4Pa.per-plasticpouches...53

9.6Wrappingtechniques...S4

55

9.6.1Simultaneousdouble-wrapping:envelopefold55

9.6.2Simultaneousdouble-wrapping:squarefold56

9.6.3Sequentialwrapping:envelopefold57

9.6.4Sequentialwrapping:squarefold

5嗡8

9.7Sterilitymaintenancecovers

9.8Rigidsterilizationcontainersystems

10Sterilization61

10.1Loadingthesterilizer61

10.1.1Generalconsiderations61

10.1.2Paper-plasticpouches61

10.1.3Instrumentsets61

10.1.44Te

61

6162

10.1.5UtensilsandglasswareA9

10.1.6Rigidsterilizationcontainersystems

10.1.7Liquids

10.1.8.8Powdersandoils

63

10.2Sterilizationparameters63

10.2.1Generalconsiderations63

10.2.2Sterilizationcycles63

10.2.3Immediate-usesteamsterilization63

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10.3Unloadingthesterilizer64

10.3.1Unloadingsterilizershavingachambervolumelargerthan2cubicfeet64

10.3.2Unloadingtable-topsterilizers(sterilizershavingachambervolumeoflessthanorequal

to2cubicfeet)64

10.4Handlingandinspectionafterunloadingthesterilizer65

11Storageandtransportation

11.1Sterilestorage66

11.1.1Storagefacilities66

11.1.2Sterilitymaintenancecovers66

11.1.3Shelflife66

11.2Distribution67

11.2.1Handlingandinspection67

11.2.2Distributioncontainers67

11.3Transportofsterilepackageditems67

11.3.1Generalconsiderations67

11.3.2Tablesandcarts(openorclosed)67

11.3.3Handtransport67

11.3.4Dedicatedlifts68

11.3.5Off-sitetransportation68

12Installation,care,andmaintenanceofsterilizers69

12.1Generalrationale嚼

12.2Instructionmanuals

12.3Installation嚏

12.4Routinecare

12.5Preventivemaintenance

..70

12.5.1Generalconsiderations...70

12.5.2Scheduledmaintenance

..7縹0

12.6Calibration

12.7Record-keeping

13Processmonitoring.testing.andqualitycontrol

13.1Generalconsiderations72

13.2Monitoringofmechanicalcleaningequipment72

13.3Productidentificationandtraceability72

13.3.1Generalconsiderations72

13.3.2Packagelabelingandexpirationdating,ifapplicable72

13.3.3Sterilizerrecords73

73

13.3.4Recordretention73

13.4Sterilizationprocessmonitoring77

13.5Sterilizationprocessmonitoringdevices77"

13.5.1Physicalmonitors

13.5.2Chemicalindicators80

13.5.3Biologicalindicators81

13.5.4Processchallengedevices82

13.6Routineloadrelease82

13.6.1Processmonitoringdevices82

82

13.6.2Releasecriteriafornonimplants83

13.6.3Releasecriteriaforimplants84

13.6.4Sterilizationprocessfailure84

13.7Routinesterilizerefficacymonitoring84

13.7.1Generalconsiderations87

13.7.2Routinebiologicalmonitoringofsterilizerslargerthan2cubicfeet88

13.7.3Routinebiologicalmonitoringoftable-topsterilizers(lessthanorequalto2cubicfeet)89

13.7.4Routinebiologicalsterilizerefficacymonitoringofgravity-displacementcycles94

13.7.5ActionstotakewhenBis,Cis,orphysicalmonitorsindicateasterilizationprocessfailure97

97

13.7.6RoutineBowie-Dicktestingofdynamic-air-removalsterilizers97

13.8Qualificationtesting

13.8.1Generalconsiderations

13.8.2Qualificationtestingofsterilizershaveachambervolumelargerthan2cubicfeet

13.8.3Qualificationtestingoftable-topsterilizers(sterilizershavingachambervolumelessthan

orequalto2cubicfeet).99

13.9Periodicproductqualityassurancetestingofroutinelyprocesseditems101

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13.9.1Generalconsiderations101

13.9.2Processverification102

13.9.3Productfamilies102

13.9.4Verificationtestingprocedure103

13.10Periodicproductqualityassurancetestingofrigidsterilizationcontainersystems104

13.10.1Generalconsiderations104

13.10.2Userresponsibilities104

14Qualityprocessimprovement106

14.1Generalconsiderations106

14.2Qualityprocess106

14.2.1Generalconsiderations106

14.2.2Qualitysystemmodel106

14.2.3Riskanalysis107

14.3Suppliercommunication110

14.4Repairrecords110

14.5Processingpoliciesandprocedures110

15Newproductevaluation111

15.1Generalrationale111

15.2Considerations111

Tables

1lES-recommendedilluminancelevelsforworkenvironments20

2Sterilizationprocessmonitoringrecommendations75

3Typesandapplicationsforuseofsterilizationmonitoringdevices76

4Potentialcausestobeinvestigatedforsteamsterilizationprocessfailures92

5Summaryoftestconfigurationsforprepurchaseevaluationofrigidsterilizationcontainersystems105

E.1Levelsofdisinfectionaccordingtotypeofmicroorganism131

E.2Occupationalexposurelimitsfo