ISO11135两个版本的比较.docx

ISO11135两个版本的比较.docx

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ISO11135两个版本的比较

Clause

2014

Influence

2007

1Scope

Nothingsignificantchangefortheindustrial

1.1Inclusion

NEW

SpecifyrequirementofEOsterilizationforindustrialandhealthcarefacility.

1.2Exclusion

NEW

1.2.1=20071,DONOTincludeseveralkindsofinactivation

1.2.2=20071,DONOTspecifyrequirementfordesignatingSTERILE

1.2.3=20071,DONOTspecifyaqualitymanagementsystem

1.2.4=2007.1,DONOTspecifyoccupationalsafety

1.2.5=2007.1,DONOTincludeinjectingEOtopackage

1.2.6=2007.1,DONOTcoveranalyticalmethodforEOresidualorreaction

2NormativeReference

ISO10012,same

ISO10993-1DELETE

ISO10993-7same

ISO11138-1:

2006same

ISO11138-2:

2009versionupdate

ISO11140-1same

ISO11737-1same

ISO11737-2same

ISO13485:

2003/Cor1:

2009,change

ISO14161DELETE

ISO14937:

2000DELETE

3TermandDefinition

DewPoint:

NEW

Healthcarefacility:

NEW

Overkillapproach:

onlytermchange

Processchallengedevice:

internalPCD/externalPCD

Processingcategory:

NEW

Producefamily:

NEW

Reusablemedicaldevice:

NEW

Singleusemedicaldevice:

NEW

SLR:

newmethodtocalculate

Sterilebarriersystem:

NEW

Sterilizationspecialist:

NEW

Testforsterility:

NEW

Virginmaterial:

NEW

4Qualitymanagementsystem

4.1Documentation

4.1.1=20074.1.1,procedurefordevelopment,validation,routinecontrolandproductreleaseshallbespecified.

4.1.2=20074.1.2,reviewedandapprovedbydesignatedpersonnel,documentandrecordaccordingtoISO13485

Noeffect

4.2Managementresponsibility

4.2.1=20074.2.1,responsibilityandauthorityshallbespecifiedaccordingtoISO13485

4.2.2=20074.2.2,organizationwithseparatequalitymanagementsystem

AddHCF’sresponsibility

Noeffect

4.3Productionrealization

4.3.1=20074.3.1,purchasingprocedure

4.3.2=20074.3.2,procedureforidentificationandtraceability

4.3.3=20074.3.3,qualitymanagementsystemforcalibration

Noeffect

4.4Measurement,analysisandimprovement

=20074.4,procedurefornonconformingproductandforcorrection,correctiveactionandpreventiveaction.

Noeffect

5Sterilizingagentcharacterization

5.1General

NEW

Purpose

5.2Sterilizingagent

=20075.1,composition,storage

Descriptionchangewhilethecontentkeepthesame

5.3Microbicidaleffectiveness

=20075.2,recognizedrangeofEOanddiluents,otherwisemicrobicidaleffectivenessshallbedeveloped.

5.4Materialeffects

=20075.3,EO’seffectonmaterialsusedtoMedicalDevice.DELETEthedescriptionofrecording

5.5Safetyandenvironment

5.5.1,NEW,MSDSofEOanddiluentsneeded,healthandsafetyofpersonnel

5.5.2=20075.4.1,environmentprotect

5.5.3=20075.4.2,userofEO

6Processandequipmentcharacterization

6.1General

6.1.1,NEW,purpose

6.1.2,NEW,ifasterilizationprocessexisting,thenignorethis

6.2Processcharacterization

6.2.1,NEW,Processcharacterizationshallinclude

a）,identifyingthephaseforEOcycle

b）,identifyingthevariablesforeachphase

c）documentthevariables

6.2.2=20076.1.2,phaseofsterilization

a）,preconditioning

b）,sterilizationcycle

c）,aeration

6.2.3,NEW,variablesforpreconditioning

a）,time

b）,temp

c）,humidity

d）,transfertime

6.2.4,NEW,variableforsterilizationcycle

a）,exposuretime

b）,temp

c）,humidity

d）,EOconcentration

e）,pressure

6.2.5,NEW,variableforaeration,noteforaerationvariable

a）,time

b）,temp

DELETE20076.1.1

DELETE20076.1.3thecharacterizationofsterilizationcycle

DELETE20076.1.4thecontrolledtreatmentcondition

DELETE20076.1.5tolerance

DELETE20076.1.6meansofmonitoringandcontrolling

●Rangeofvariableandequipmentshallbedocumented

6.3Equipmentcharacterization

6.3.1=20076.2.1,specificationofequipmentshallinclude

a）,thepreconditioningarea

b）,thesterilizer

c）,theaerationarea

6.3.2=20076.2.2,specificationshallinclude

a）=2007a）,descriptionofequipment,ancillaryitems,materialofconstruction

b）<2007b）,descriptionofmeansofdeliveringsterilizingagenttochamber

c）=2007c）,descriptionofmeansofdeliveringothergasorsteamtochamber

d）=2007e）,descriptionofinstrumentationformonitoring,controllingandrecording

e）=2007f）,faultrecognition

f）=2007g）,safetyfeature

g）=2007h）,installationrequirement

6.3.3=20076.2.3,softwareshallbepreparedandvalidatedtomeetitsspecification

6.3.4=20076.2.4,meanstoensurefailureincontrolfunctiondoesnotleadtofailureinrecordingwhichleadtoafakepositive

7Productdefinition

7.1General

7.1.1,NEW,purpose:

definetheproducttobesterilizedpriortothesterilization,includingthemicrobiologicalqualityandpackage

7.1.2=20077.1.1+7.1.2

7.1.3<20077.1.3,productshallbedesignedtoallowtheremovalofairandEO,etc,DELETEthemostdifficult-to-sterilizedlocationforproduct

7.1.4=20077.1.4,packageshallbedesignedtoallowtheremovalofairandEO,etc

7.1.5,NEW,loadconfigurationshallbedesignedtoallowtheremovalofairandEO,etc

7.1.6>20077.1.5,Itcanbeachievedby3waystodemonstratethespecifiedsterilizationprocessiseffectiveinsterilizingthemostdifficult-to-sterilizelocationwithintheproductinsteadofmaybe.

7.2Productsafety,qualityandperformance

7.2.1=20077.2.1,themostchallengingprocessparameterofproductandpackage.

7.2.2<20077.2.2,evaluatemultiplecycle’seffectonproduct,DELETEISO17664

7.2.3=20077.2.3,establishthebiologicalsafetyofproductenduredthecycle

7.2.4=20077.2.4,reducetheEOresidual

7.3Microbiologicalquality

7.3.1=20077.3.1,systemtocontrolmicrobiologicalqualityandcleanliness.Addquotationofbacterialendotoxinsrelatedstandardandliterature.

7.3.2=20077.3.2,system’seffectivenessforsingleandreusablemedicaldeviceshallbedemonstrated.

7.4Documentation

>20077.4,documentationshallbedonebymanufacturerofthedevice

8Processdefinition

8.1

NEW,purpose,obtainaprocessspecificationforthesterilizationofproductduringthevalidationstudies.

8.2

=20078.1+8.3,sterilizationshallbeestablishedfornewormodifiedproduct,packagingorloadingconfiguration.

8.3

=20078.2,sterilizationchambershallbeIQedandOQed.

8.4

=20078.4,documentationandrecords

8.5

=20078.5,rateofmicrobiologicalinactivationshallbedeterminedbythemethodprovidedinannexesoralternativemethodachievingthesameSAL

8.6

=20078.6,BIandPCDrequirement

8.7

=20078.7,commerciallysuppliedBIrequirementshallcomplywith8.6andISO11138-1

8.8

=20078.8,chemicalindicatorsshallcomplywithISO11140-1

8.9

=20078.9,testofsterilityshallcomplywithISO11737-2

9Validation

9.1General

New

9.1.1,Purpose,validationconsistsof3stages:

IQ,OQ,PQ.

9.1.2,PurposeofIQ

9.1.3,PurposeofOQ

9.1.4,PurposeofPQ,differenceofIOQandPQ

9.2IQ

=20079.1

9.2.1Equipment

New

9.2.1.1=20079.1.1and9.1.2

9.2.1.2,Newsafetystandard

9.2.1.3=20079.1.3

9.2.2IQ

New

9.2.2.1,architecturalandengineeringdrawingandregulation

9.2.2.2=20079.1.5,instructionforinstallationandhealthandsafetyofpersonnel

9.2.2.3,safeEOstorage=20079.1.4Example

9.2.2.4,calibration

9.2.2.5=20079.1.6drawingofequipmentshallbefinalizedduringIQ.

9.2.2.6,changeofsystemshallbeassessedanddocumentedinDHF

9.3OQ

9.3.1=20079.2.1,calibrationofinstrumentation

9.3.2=20079.2.2,equipmentiscapableofmeetingitsoperatingspecification.

9.4PQ

9.4.1General

9.4.1.1,PQconsistsofmicrobiologicalandphysicalPQ

9.4.1.2=20079.3.1.1,whentoperformPQ

9.4.1.3=20079.3.1.2,objectusedinPQ

9.4.1.4=20079.3.1.4+9.3.1.3,mannerofpresentingproductandloadingpatternshallbespecifiedandthesealableproductrequirement

9.4.1.5=20079.3.1.3,loadrequirement

9.4.1.6=20079.4

9.4.1.7=20079.3.1.3,materialotherthanproduct

9.4.1.8=20079.3.1.3,reusedload

9.4.1.9=20079.3.1.5,chemicalindicatorcomplywithISO11140-1andconjunctionwithmicrobiologicalandphysicalmonitoring

9.4.1.10,BIcomplywithISO11138

9.4.2PQ-Microbiological

9.4.2.1=20079.3.2.1,MPQshalldemonstratespecifiedrequirementforsterilityismetonapplicationofthesterilizationprocess.

9.4.2.2=20079.3.2.2,MPQshallconfirmtheeffectivenessofdefinedprocess

9.4.2.3=20079.3.2.3,LethalityofprocessshallbedeterminedusingthemethodinannexoralternativemethodwithachievingtherequiredSAL

9.4.2.4=20079.3.2.4,developmentalchamberrequirement

9.4.2.5,overkillhalfcycleapproach,internalandexternalPCDrequirement

9.4.2.6,overkillcyclecalculationapproachorBI/bioburdenapproach,internalPCDandSALrequirement

9.4.3PQ-Physical

9.4.3.1≈20079.3.3.1,PhysicalPQshalldemonstratethereproducibilityandspecifiedacceptancecriteriaismet.

9.4.3.2≈20079.3.3.2,PPQshallconfirmtheprocess

a）addtheminimumtempofproducttoenterthecycle

b）=2007a）,loadtempattheendofpreconditioningtime

c）=2007b）,maximumtimebetweencompletionofpreconditioningandcommencementofcycle

d）addtheloadtempandhumidityandtheendofconditioning

e）addthehumidityisrecordedifparametricreleasewastobeused

f）=2007c）,gaseousEOisadmittedtothechamber

g）=2007d）,pressurerise,qualityandconcentrationofEOrecordedifparametricreleaseistobeused

h）=2007e）,tempandhumidityofthechamberandotherparameterisrecordedifparametricreleaseistobeused

i）=2007f）,tempofloadduringEOexposure

j）=2007g）,tempofloadduringaeration

9.5Reviewandapprovalofvalidation

9.5.1=20079.5.1,purpose

9.5.2=200