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1、ENISO22675May2025EUROPEANSTANDARDNORMEEUROPEENNEEuropaischenormICS11.040.40SupersedesENISO22675:2016EnglishVersionProsthetics-Testingofankle-footdevicesandfootunits-RequirementsandtestmethodsISO22675:2024Protheses-Essaisd,articulationscheville-piedetunitesdepied-Exigencesetmethodesdessai(ISO22675:20
2、24)Prothetik-PriifungvonKnochel-FuE-PassteilenundFuEeinheiten-AnforderungenundPriifverfahren(ISO22675:2024)ThisEuropeanStandardwasapprovedbyCENon19November2024.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationals
3、tandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytranslationunderth
4、eresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Lat
5、via,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:Ruede
6、laScience23,B-1040BrusselsRef.No.ENISO22675:2025E2025CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.EuropeanforewordThisdocument(ENISO22675:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC168ProstheticsandorthoticsincollaborationwithTechnicalCommitteeCEN/TC293nA
7、ssistiveproductsandaccessibilitythesecretariatofwhichisheldbySIS.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyNovember2025,andconflictingnationalstandardsshallbewithdrawnatthelatestbyNovember2025.Attentionisdrawntothepo
8、ssibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO22675:2016.ThisdocumenthasbeenpreparedunderastandardizationrequestaddressedtoCENbytheEuropeanCommission.TheStandingCommitteeoftheEFT
9、AStatessubsequentlyapprovestheserequestsforitsMemberStates.FortherelationshipwithEULegislation,seeinformativeAnnexZA,whichisanintegralpartofthisdocument.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody/nationalcommittee.Acompletelistingofthesebodiescanbefoundonthe
10、CENwebsite.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,L
11、uxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO22675:2024hasbeenapprovedbyCENasENISO22675:2025withoutanymodification.AnnexZA(informative)Relationshipbetween
12、thisEuropeanstandardandtheGeneralSafetyandPerformanceRequirementsofRegulation(EU)2017/745aimedtobecoveredThisEuropeanstandardhasbeenpreparedunderM/575toprovideonevoluntarymeansofconformingtotheGeneralSafetyandPerformanceRequirementsofRegulation(EU)2017/745of5April2017concerningmedicaldevices0JL117an
13、dtosystemorprocessrequirementsincludingthoserelatingtoqualitymanagementsystems,riskmanagement,post-marketsurveillancesystems,clinicalinvestigations,clinicalevaluationorpost-marketclinicalfollow-up.OncethisstandardiscitedintheOfficialJournaloftheEuropeanUnionunderthatRegulation,compliancewiththenorma
14、tiveclausesofthisstandardgiveninTableZA.1confers,withinthelimitsofthescopeofthisstandard,apresumptionofconformitywiththecorrespondingGeneralSafetyandPerformanceRequirementsofthatRegulation,andassociatedEFTARegulations.WhereadefinitioninthisstandarddiffersfromadefinitionofthesametermsetoutinRegulatio
15、n(EU)2017/745,thedifferencesshallbeindicatedinthisAnnexZ.ForthepurposeofusingthisstandardinsupportoftherequirementssetoutinRegulation(EU)2017/745,thedefinitionssetoutinthisRegulationprevail.WheretheEuropeanstandardisanadoptionofanInternationalStandard,thescopeofthisstandardcandifferfromthescopeofthe
16、EuropeanRegulationthatitsupports.Asthescopeoftheapplicableregulatoryrequirementsdifferfromnationtonationandregiontoregion,thestandardcanonlysupportEuropeanregulatoryrequirementstotheextentofthescopeoftheEuropeanregulationformedicaldevices(EU)2017/745).NOTE1Whereareferencefromaclauseofthisstandardtotheriskmanagementprocessismade,theriskmanagementprocessneedstobeincompliancewithRegulat
