1、BRITISH STANDARD BS EN ISO 17664:2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices The European Standard EN ISO 17664:2004 has the status of a British Standard ICS 11.080.01 BS EN ISO 17664:2004 This British Stan
2、dard was published under the authority of the Standards Policy and Strategy Committee on 12 March 2004 BSI 12 March 2004 ISBN 0 580 43550 4 National foreword This British Standard is the official English language version of EN ISO 17664:2004. It is identical with ISO 17664:2003. The UK participation
3、 in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international
4、or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to in
5、clude all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enq
6、uiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, pages 2 to 23 and a
7、back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO17664 March2004 ICS11.080.01 Englishversion SterilizationofmedicaldevicesInformat
8、iontobeprovidedby themanufacturerfortheprocessingofresterilizablemedical devices StrilisationdesdispositifsmdicauxInformationsdevant trefourniesparlefabricantpourleprocessusdere strilisationdesdispositifsmdicaux(ISO17664:2004) SterilisationvonMedizinproduktenVomHersteller bereitzustellendeInformatio
9、nenfrdieAufbereitungvon resterilisierbarenMedizinprodukten(ISO17664:2004) ThisEuropeanStandardwasapprovedbyCENon3November2003. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Upt
10、odatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsown
11、languageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Po
12、rtugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers
13、 Ref.No.ENISO17664:2004:EENISO17664:2004(E) 2 Contents Page Foreword .3 Introduction.4 1 Scope5 2 Termsanddefinitions . 5 3 Informationtobeprovidedbythemedicaldevicemanufacturer 7 3.1 Reprocessinginstructions . 7 3.2 Limitationsandrestrictionsonreprocessing 7 3.3 Preparationatthepointofusepriortopr
14、ocessing . .7 3.4 Preparationbeforecleaning. 8 3.5 Cleaning .8 3.6 Disinfection 8 3.7 Drying .9 3.8 Inspection,maintenanceandtesting . .9 3.9 Packaging.10 3.10 Sterilization 10 3.11 Storage .10 4 Presentationoftheinformation. 10 5 Validationofthereprocessinginformationprovided11 6 Riskanalysis. .11
15、AnnexA (informative) Commonlyutilizedreprocessingmethods12 A.1 General .12 A.2 Matrixforidentifyingmethodsofprocessing 13 AnnexB (informative) Anexampleofreprocessinginstructionsforreusablemedicaldevices .17 AnnexZA (informative) ClausesofthisEuropeanStandardaddressingessential requirementsorotherpr
16、ovisionsofEUDirectives.22 Bibliography23ENISO17664:2004(E) 3 Foreword Thisdocument(ENISO17644:2004)hasbeenpreparedbyTechnicalCommitteeCEN/TC 204 “Sterilizationofmedicaldevices“,thesecretariatofwhichisheldbyBSI,incollaborationwith TechnicalCommitteeISO/TC198“Sterilizationofhealthcareproducts“. ThisEu
17、ropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofan identicaltextorbyendorsement,atthelatestbySeptember2004,andconflictingnationalstandards shallbewithdrawnatthelatestbySeptember2004. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionand theEuropeanF
18、reeTradeAssociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthis document. InformativeannexesAandBareattachedtothisdocument. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthe fo
19、llowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Luxembourg, Malta,Netherlands,Norway,Portugal,Slovakia,Spain,Sweden,SwitzerlandandtheUnited Kingdom.ENISO17664:2004(E) 4 Introduction Thisstandar
20、dappliestothosemedicaldeviceswhichareintendedformultipleuseandrequire processingtotakethemfromtheirstateattheendofoneusetothestateofbeingsterileandready fortheirsubsequentuse.Somemedicaldevicessuppliednonsterilebutintendedtobeusedina sterilestate,willalsorequiresimilartreatment.ENISO17664:2004(E) 5
21、1Scope Thisstandardspecifiestheinformationtobeprovidedbythemedicaldevicemanufactureronthe processingofmedicaldevicesclaimedtoberesterilizableandmedicaldevicesintendedtobe sterilizedbytheprocessor. Thisstandardspecifiesrequirementsfortheinformationtobeprovidedbythemedicaldevice manufacturer,sothatthe
22、medicaldevicecanbeprocessedsafelyandwillcontinuetomeetits performancespecification. Requirementsarespecifiedforprocessingthatconsistsofallorsomeofthefollowingactivities: preparationatthepointofuse; preparation, cleaning, disinfection; drying; inspection,maintenanceandtesting; packaging; sterilizatio
23、n; storage. Whenprovidinginstructionsfortheseactivities,medicaldevicemanufacturersareexpectedtobe awareofthetrainingandknowledgeofprocedures,andoftheprocessingequipmentavailabletothe personslikelytoberesponsibleforprocessing.Itislikelythatsomeprocessingprocedureswillbe genericandwellknownandwillusee
24、quipmentandconsumablesconformingtorecognized standards.Inthiscase,areferenceintheinstructionsisallthatisrequired.Forthosemedicaldevices whereinstructionsforusearenotrequiredtoaccompanythemedicaldevice,othermeansof communicatingtheinformationcanbeused,e.g.usermanuals,symbolsorwallchartssupplied separ
25、ately. Thisstandardexcludestextiledevicesusedinpatientdrapingsystemsorsurgicalclothing. NOTE Theprinciplesofthisstandardmaybeappliedwhenconsideringtheinformationtobesuppliedwith medicaldeviceswhichonlyrequiredisinfectionpriortoreuse. 2 Termsanddefinitions ForthepurposesofthisEuropeanStandard,thefoll
26、owingtermsanddefinitionsapply. 2.1 chemical formulationofcompoundsintendedforuseinreprocessing NOTE Thisincludes,forexample,detergents,surfactants,rinseaids,disinfectants,enzymaticcleaners, sterilants. 2.2 cleaning removalofcontaminationfromanitemtotheextentnecessaryforfurtherprocessingorforintended
27、 useENISO17664:2004(E) 6 2.3 disinfection processusedtoreducethenumberofviablemicroorganismsonaproducttoalevelpreviously specifiedasappropriateforitsfurtherhandlingoruse 2.4 manualcleaning cleaningwithouttheuseofawasherdisinfector 2.5 manufacturer organizationwithresponsibilityforthedesign,manufactu
28、re,packagingandlabellingofadevice beforeitisplacedonthemarketunderitsownname,regardlessofwhethertheseoperationsare carriedoutbythatpersonhimselforonitsbehalfbyathirdparty 2.6 processing activityincludingcleaning,disinfectionandsterilization,necessarytoprepareaneworusedmedical deviceforitsintendeduse
29、 2.7 processor organizationwiththeresponsibilityforcarryingouttheactionsnecessarytoprepareaneworused deviceforitsintendeduse 2.8 sterilant chemicalwhichhaspropertiestodestroymicroorganismsincludingviruses,whenusedatcorrect dilution/doseandappliedforrecommendedexposuretime 2.9 sterile freefromallviab
30、lemicroorganisms 2.10 sterilization processusedtorenderadevicefreefromallformsofviablemicroorganisms NOTE Inasterilizationprocess,thenatureofmicrobiologicaldeathisdescribedbyanexponentialfunction. Therefore,thepresenceofmicroorganismsonanyindividualitemmaybeexpressedintermsofprobability. Whistthispr
31、obabilitymaybereducedtoaverylownumber,itcanneverbereducedtozero.(SeeISO11134). Thisprobabilitycanonlybeassuredforvalidatedprocesses. 2.11 validation documentedprocedureforobtaining,recordingandinterpretingtheresultsrequiredtoestablishthata processwillconsistentlyyieldproductcomplyingwithpredetermine
32、dspecifications 2.12 verification confirmationbyexaminationandprovisionofobjectiveevidencethatspecifiedrequirementshave beenfulfilledENISO17664:2004(E) 7 2.13 washerdisinfectors machineintendedtocleananddisinfectmedicaldevicesandotherarticlesusedinthecontextof medical,dental,pharmaceuticalandveterin
33、arypractice NOTE1 Thistypeofmachinedoesnotincludethosedesignedspecificallytowashlinenorclothing.Machines intendedtosterilize,ordesignatedassterilizers,arespecifiedinotherstandardse.g.EN285. NOTE2 Preliminary standards for washerdisinfectors (prEN15883) are being prepared in an ISO CENproject. 3 Info
34、rmationtobeprovidedbythemedicaldevicemanufacturer 3.1Reprocessinginstructions Atleastonevalidatedmethodforreprocessingthemedicaldeviceshallbespecified. Thefollowinginformationshallbestatedwhereitiscriticaltothemaintenanceoftheintended functionofthemedicaldeviceandthesafetyoftheuser(s)andthepatient:
35、detailsofprocesssteps; adescriptionofspecialequipmentand/oraccessories; specificationofprocessparametersandtheirtolerances. NOTE FurtherinformationisprovidedinannexA. 3.2 Limitationsandrestrictionsonreprocessing Themanufacturershalldetermineifprocessinginaccordancewiththeprovidedinstructionsleadstoa
36、 degreeofdegradationthatwilllimittheusefullifeofthemedicaldevice.Wheresuchdegradationis established,themanufacturershallprovideanindicationofthenumberofreprocessingcyclesthat cannormallybetolerated,orsomeotherindicationoftheendofthemedicaldevicesabilitytosafely fulfilitsintendeduse. 3.3Preparationat
37、thepointofusepriortoprocessing Requirementsforpreparationatthepointofusetoensuresatisfactoryreprocessingofthemedical device,shallbespecified,ifapplicable. Whereappropriate,atleastthefollowinginformationshallbeincluded: thecontainersfortransportation; adescriptionofthesupportsystems; themaximumperiod
38、oftimethatmayelapsebetweenuseandcleaning; adescriptionoftheprecleaningtechniquescriticaltofurtherprocessing; therequirementsfortransportation.ENISO17664:2004(E) 8 3.4Preparationbeforecleaning Requirementsforthepreparationofthemedicaldevicepriortocleaningshallbespecifiedif applicable.Whereappropriate
39、instructionsforatleastthefollowingproceduresshallbegiven: therequirementsforcapping/openingofports; disassemblyofthedevice; leaktestingthedevice; soaking/brushingtechniquesrequired; ultrasonictreatmentofthedevice. Ifspecialtoolsarerequiredfordisassembly/reassembly,theseshallbespecifiedintheinstruct
40、ions. 3.5Cleaning Avalidatedmethodofmanualcleaningshallbespecified.Atleastonevalidatedautomatedmethod usingawasherdisinfectorshallalsobespecifiedunlessthemedicaldevicecannotwithstandany suchprocess,inwhichcaseawarningshouldbeissued. Whereappropriate,atleastthefollowinginformationshallbeincluded: ade
41、scriptionoftheaccessoriesrequiredforcleaningprocess; identificationandconcentrationofchemicalsrequiredforcleaning; identificationofwaterqualitytobeusedfortheprocess; limitsandmonitoringofchemicalresiduesremainingonthedevice; limitsontemperature,concentrationofsolution(s),exposuretimetobeused; thepro
42、cesstemperature(s)tobeused; thetechniquestobeusedincludingrinsing. NOTE CleaningandDisinfectingProcessingEquipmentshouldbequalifiedandvalidatedtoensure suitabilityforitsintendedpurpose. 3.6Disinfection Avalidatednonautomaticmethodofdisinfectionshallbespecified.Atleastonevalidatedautomated methodusin
43、gawasherdisinfectorshallalsobespecifiedunlessthemedicaldevicecannotwithstand anysuchprocess. Whereappropriate,atleastthefollowinginformationshallbeincluded: adescriptionoftheaccessoriesrequiredforthedisinfectionprocess; thecontacttimeofthedisinfectant; identificationandconcentrationofchemicalsrequiredforthedisinfectionprocess; identificationofwaterqualityrequiredfortheprocess;ENISO17664:2004(E) 9 thelimitsandmonitoringofchemicalresiduesremainingonthedevice; thelimitsontemperature,concentrationofsolution(s),exposuretime; theprocesstemperature(s)tobeused; the
