EN ISO 22675 2025.docx

ENISO22675May2025EUROPEANSTANDARDNORMEEUROPEENNEEuropaischenormICS11.040.40SupersedesENISO22675:2016EnglishVersionProsthetics-Testingofankle-footdevicesandfootunits-RequirementsandtestmethodsISO22675:2024Protheses-Essaisd,articulationscheville-piedetunitesdepied-Exigencesetmethodesd'essai(ISO22675:2024)Prothetik-PriifungvonKnochel-FuE-PassteilenundFuEeinheiten-AnforderungenundPriifverfahren(ISO22675:2024)ThisEuropeanStandardwasapprovedbyCENon19November2024.CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementCentreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.CENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandUnitedKingdom.EUROPEANCOMMITTEEFORSTANDARDIZATIONCOMITEEUROPEENDENORMALISATIONEuropaischeskomiteefurnormungCEN-CENELECManagementCentre:RuedelaScience23,B-1040BrusselsRef.No.ENISO22675:2025E©2025CENAllrightsofexploitationinanyformandbyanymeansreservedworldwideforCENnationalMembers.EuropeanforewordThisdocument(ENISO22675:2025)hasbeenpreparedbyTechnicalCommitteeISO/TC168"Prostheticsandorthotics"incollaborationwithTechnicalCommitteeCEN/TC293nAssistiveproductsandaccessibility"thesecretariatofwhichisheldbySIS.ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextorbyendorsement,atthelatestbyNovember2025,andconflictingnationalstandardsshallbewithdrawnatthelatestbyNovember2025.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.CENshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.ThisdocumentsupersedesENISO22675:2016.ThisdocumenthasbeenpreparedunderastandardizationrequestaddressedtoCENbytheEuropeanCommission.TheStandingCommitteeoftheEFTAStatessubsequentlyapprovestheserequestsforitsMemberStates.FortherelationshipwithEULegislation,seeinformativeAnnexZA,whichisanintegralpartofthisdocument.Anyfeedbackandquestionsonthisdocumentshouldbedirectedtotheusers'nationalstandardsbody/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite.AccordingtotheCEN-CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,RepublicofNorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,TiirkiyeandtheUnitedKingdom.EndorsementnoticeThetextofISO22675:2024hasbeenapprovedbyCENasENISO22675:2025withoutanymodification.AnnexZA(informative)RelationshipbetweenthisEuropeanstandardandtheGeneralSafetyandPerformanceRequirementsofRegulation(EU)2017/745aimedtobecoveredThisEuropeanstandardhasbeenpreparedunderM/575toprovideonevoluntarymeansofconformingtotheGeneralSafetyandPerformanceRequirementsofRegulation(EU)2017/745of5April2017concerningmedicaldevices0JL117andtosystemorprocessrequirementsincludingthoserelatingtoqualitymanagementsystems,riskmanagement,post-marketsurveillancesystems,clinicalinvestigations,clinicalevaluationorpost-marketclinicalfollow-up.OncethisstandardiscitedintheOfficialJournaloftheEuropeanUnionunderthatRegulation,compliancewiththenormativeclausesofthisstandardgiveninTableZA.1confers,withinthelimitsofthescopeofthisstandard,apresumptionofconformitywiththecorrespondingGeneralSafetyandPerformanceRequirementsofthatRegulation,andassociatedEFTARegulations.WhereadefinitioninthisstandarddiffersfromadefinitionofthesametermsetoutinRegulation(EU)2017/745,thedifferencesshallbeindicatedinthisAnnexZ.ForthepurposeofusingthisstandardinsupportoftherequirementssetoutinRegulation(EU)2017/745,thedefinitionssetoutinthisRegulationprevail.WheretheEuropeanstandardisanadoptionofanInternationalStandard,thescopeofthisstandardcandifferfromthescopeoftheEuropeanRegulationthatitsupports.Asthescopeoftheapplicableregulatoryrequirementsdifferfromnationtonationandregiontoregion,thestandardcanonlysupportEuropeanregulatoryrequirementstotheextentofthescopeoftheEuropeanregulationformedicaldevices(EU)2017/745).NOTE1Whereareferencefromaclauseofthisstandardtotheriskmanagementprocessismade,theriskmanagementprocessneedstobeincompliancewithRegulat