1、BRITISH STANDARD BS EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing The European Standard EN 13532:2002 has the status of a British Standard ICS 11.100 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 13532:2002 This British Stan
2、dard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 8 May 2002 BSI 8 May 2002 ISBN 0 580 39682 7 National foreword This British Standard is the official
3、English language version of EN 13532:2002. The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-refere
4、nces The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalo
5、gue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text
6、; present to the responsible European committee any enquiries 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 f
7、ront cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN13532 April200
8、2 ICS11.100 Englishversion Generalrequirementsforinvitrodiagnosticmedicaldevicesfor selftesting Exigencesgnralesrelativesauxdispositifsmdicauxde diagnosticinvitrodestinsdesautodiagnostics AllgemeineAnforderungenanInvitroDiagnostikazur Eigenanwendung ThisEuropeanStandardwasapprovedbyCENon27December20
9、01. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoa
10、nyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAus
11、tria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36
12、B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN13532:2002EEN13532:2002(E) 2 Foreword ThisdocumentEN13532hasbeenpreparedbyTechnicalCommitteeCEN/TC140“Invitrodiagnosticmedical devices“,thesecretariatofwhichisheldbyDIN. ThisEuropeanS
13、tandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyOctober2002,andconflictingnationalstandardsshallbewithdrawnatthelatest byOctober2002. ThisdocumenthasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandtheEuropean FreeTradeAss
14、ociation,andsupportsessentialrequirementsofEUDirective(s). ForrelationshipwithEUDirective(s),seeinformativeannexZA,whichisanintegralpartofthisdocument. ThisstandardincludesaBibliography. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoi
15、mplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN13532:2002(E) 3 1 Scope ThisEuropeanStandardspecifiesgeneralrequirementsforinvitrodiagno
16、sticmedicaldevices(IVD MDs)for selftestinginordertoensurethatIVDMDsforselftestingaresafeandsuitableforthepurposesasspecifiedbythe manufacturer. ThisstandarddoesnotaddressmedicalaspectsofIVDMDsforselftesting. 2 Normativereferences ThisEuropeanStandardincorporatesbydatedorundatedreference,provisionsfr
17、omotherpublications.These normativereferencesarecitedattheappropriateplacesinthetext,andthepublicationsarelistedhereafter.Fordated references,subsequentamendmentstoorrevisionsofanyofthesepublicationsapplytothisEuropeanStandardonly whenincorporatedinitbyamendmentorrevision.Forundatedreferencesthelate
18、steditionofthepublicationreferred toapplies(includingamendments). EN376, Informationsuppliedbythemanufacturerwithinvitrodiagnosticreagentsforselftesting. EN592, Instructionsforuseforinvitrodiagnosticinstrumentsforselftesting. EN1658, Requirementsformarkingofinvitrodiagnosticinstruments. EN13612, Per
19、formanceevaluationofinvitrodiagnosticmedicaldevices. EN610101:2001, Safetyrequirementsforelectricalequipmentformeasurement,controlandlaboratoryusePart1: Generalrequirements(IEC610101:2001). EN61326, Electricalequipmentformeasurement,controlandlaboratoryuseEMCrequirements(IEC61326:1997). 3 Termsandde
20、finitions ForthepurposesofthisEuropeanStandard,thefollowingtermsanddefinitionsapply. 3.1 invitrodiagnosticmedicaldevice anymedicaldevicewhichisareagent,reagentproduct,calibrator,controlmaterial,kit,instrument,apparatus, equipmentorsystem,whetherusedaloneorincombination,intendedbythemanufacturertobeu
21、sedinvitroforthe examinationofspecimens,includingbloodandtissuedonations,derivedfromthehumanbody,solelyorprincipallyfor thepurposeofprovidinginformationconcerningaphysiologicalorpathologicalstate,orconcerningcongenital abnormality,ortodeterminethesafetyandcompatibilitywithpotentialrecipients,ortomon
22、itortherapeuticmeasures NOTE1Aspecimenreceptacle,whethervacuumtypeornot,specificallyintendedbyitsmanufacturerfortheprimarycontainmen t andpreservationofspecimensderivedfromthehumanbodyforthepurposeofinvitrodiagnosticexaminationisconsideredtob ean invitrodiagnosticmedicaldevice. NOTE2Productsforgener
23、allaboratoryusearenotinvitrodiagnosticmedicaldevicesunlesssuchproducts,inviewoftheir characteristics,arespecificallyintendedbytheirmanufacturertobeusedforinvitrodiagnosticexamination. 3.2 layperson individualwhodoesnothavespecificmedicaleducation EN376:2002 3.3 marking inscription,inwritingorasagrap
24、hicalsymbol,permanentlyaffixedtoaproduct NOTEExamplesforinscriptionsaremanufacturersordistributorstrademark,modelortypenumber,identificationofintended functions,supplyvoltage,particularwarnings.EN13532:2002(E) 4 3.4 permanentlyaffixed removableonlywithatoolorbyappreciableforceandabletowithstandtheef
25、fectsoftemperature,rubbing,common solvents,reagents,andvapoursencounteredduringnormaluse 3.5 selftesting useinthehomeorsimilarenvironmentsbyalaypersonwhowillrelatetheresultofthetesttohimorherself EN376:2002 4 Designcriteria 4.1 Ergonomicandhumanfactoraspects ThedesignofIVDMDsforselftestingshalltaket
26、hefollowingergonomicandhumanfactorsintoconsideration: identificationofintendedusers; easeofoperation; easeofusermaintenance; readabilityofthetestresults; easeofinterpretationoftheinstructionsforuse; easeofverificationbytheuserofthecorrectfunctioningoftheIVDMDforselftesting; reasonablyforeseeablevari
27、ationsinthewayinwhichtheuserperformsthetest; reasonablyforeseeablevariationsintheenvironmentinwhichthetestisperformed; reasonablyforeseeablemisuse. Whentakingthesefactorsintoaccount,considerationshallbegiventopotentiallimitationsinskillsandcapabilitiesof usersforwhomtheIVDMDforselftestingisintended.
28、 4.2 Electromagneticcompatibility EN61326shallapply,ifrelevant. 4.3 Protectionagainstelectricshock EN610101:2001,clause6,shallapply,ifrelevant. 4.4 Protectionagainstmechanicalhazards EN610101:2001,clause7,shallapply,ifrelevant. 4.5 Mechanicalresistancetoshock,vibrationandimpact EN610101:2001,clause8
29、,shallapply,ifrelevant.EN13532:2002(E) 5 4.6 Equipmenttemperatureexposurelimits EN610101:2001,clause10,shallapply. 4.7 Resistancetoheat EN610101:2001,clause10aswellas12.3and12.4,shallapply. Additionally,itshallbetakenintoaccountthatheatmaybegeneratedbynaturalsunlightandothervisiblelight sources. 4.8
30、 Resistancetomoistureandliquids EN610101:2001,11.1,11.2and11.3,shallapply. 4.9 Protectionagainstliberatedgases,explosionandimplosion EN610101:2001,13.1and13.2,shallapply,ifrelevant. 4.10 Components EN610101:2001,14.1,14.4,14.5and14.6,shallapply. 4.11 Riskanalysis Themanufacturershalldecideontheaccep
31、tabilityofpotentialriskofsuchfactorsas: unforeseenuseoftheIVDMDforselftestinginapotentiallyunsuitableenvironment(e.g.travel,hotel); limitationsofskillsandmeansavailabletolayusers; limitationsofspecifiedperformancecharacteristics; probabilityofoccurrenceoffailure; consequenceofafailure; inappropriate
32、disposal. NOTE ThissubclausereferstoEN 1441.Thisstandarddoesnotstipulatelevelsofacceptab ilitywhich,becausetheyare determinedbyamultiplicityoffactors,cannotbytheirnaturebesetdowninsuchastandard.Thisstandardisnotintendedt ogive detailedguidanceonmanagementofri sks.Furthermore,itisnotint endedtocoverd
33、ecisionmakingprocessesregarding assessmentoftheindicationsandcontraindicationsfortheuseofaparticularIVDMDforselftesting. 4.12 Designchange ChangestothedesignofanIVDMDforselftestingwhicharemadeafterithasbeenputontothemarketandwhich affect thespecifications; theperformance; themarkingandinformationsup
34、pliedbythemanufacturerifignoringsuchchangescouldleadtoerroneous results;EN13532:2002(E) 6 aspectsofsafetyoftheuserorathirdparty shallberegardedassignificant.Suchchangesshallbesubmittedtoriskanalysisandevaluation. 5 Markingsandinformationsuppliedbythemanufacturer 5.1 MarkingsandlabelsofIVDMDsforselft
35、esting WhereanIVDMDforselftestinginvolvestheuseofaninstrument,themarkingoftheinstrumentshallbein accordancewithEN 1658.Inaddition,theIVD instrumentsforselftestingshallbearthefollowingmarkings,if appropriate,e.g.ifnotnotedintheinstructionsforuseoftheinstrumentoronthelabelorintheinstructionsforuseof t
36、hereagentsnecessarytoperformtherespectiveselftesting: intendedpurpose; astatementthattheinstrumentisintendedforselftesting; areferencetotheinstructionsforuse. WhereanIVDMDforselftestinginvolvestheuseofareagent,reagentproduct,calibrator,controlmaterial,kitand/or otherconsumables,theseelementsshallbel
37、abelledaccordingtoEN376. 5.2 InstructionsforuseofIVDMDsforselftesting AnyinstructionsforuseofinstrumentsshallbeinaccordancewiththerequirementsgiveninEN592. Anyinstructionsforuseofreagents,reagentproducts,calibrators,controlmaterials,kitsand/orotherconsumables shallbeinaccordancewiththerequirementsgi
38、veninEN376. 6 Performanceevaluation EN13612shallapply. 7 Userverification Userverification,ifreasonablypossible,shallallowtheusertocheckatthetimeofuse correctfunctioningoftheIVDMDforselftesting,i.e.systemcontrol, correctexecutionofthetestincludingsequenceoftheproceduralsteps. NOTE“Atthetimeofuse“mea
39、nsimmediatelybefore,during,orimmediatelyaftertheexecutionoftherespectiveselftest. Userverificationshallbeintegratedintothetestwhereverreasonablypossible.Userverificationshouldgive unambiguousinformation.Theinstructionsforuseshallclearlyandinsimpletermsstatewhattodoiftheverification indicatesaninvali
40、dresult.EN13532:2002(E) 7 AnnexZA (informative) ClausesofthisEuropeanStandardaddressingessentialrequirementsorother provisionsofEUDirectives ThisEuropeanStandardhasbeenpreparedunderamandategiventoCENbytheEuropeanCommissionandthe EuropeanFreeTradeAssociation,andsupportsessentialrequirementsoftheEUDir
41、ective98/79/EC. WARNING:OtherrequirementsandotherEUDirectivesmaybeapplicabletotheproduct(s)fallingwithinthe scopeofthisstandard. Thefollowingclausesofthisstandard,asdetailedinTable ZA.1,arelikelytosupportrequirementsofthe EUDirective98/79/EC. Compliancewiththeseclausesofthisstandardprovidesonemeanso
42、fconformingtothespecificessential requirementsoftheDirectiveconcernedandassociatedEFTAregulations. TableZA.1CorrespondencebetweenthisEuropeanStandardandEUDirective98/79/EC Clauses/subclausesofthis EuropeanStandard Essentialrequirementsof EUDirective98/79/EC Qualifyingremarks/notes 4.1 B.3.3.1,B.3.6,
43、B.7,B.7.1,B.7.2,B.8.7(t) 4.2 B.3.3,B.6.2 4.3 B.3.3.2,B.6.3,B.6.4.4 4.4 B.3.3.1,B.6.4 4.5 B.6.4.2 4.6 B.3.3.2 4.7 B.3.3.2 4.8 B.1.2 4.9 B.3.4 4.10 B.3.1 4.11 A.1,A.2,A.4,A.5 5.1 B.8,B.8.4 5.2 B.8,B.8.7, 7 B.7.2,B.8.7(t)EN13532:2002(E) 8 Bibliography EN1441, MedicaldevicesRiskanalysis. ENISO14971, Med
44、icaldevicesApplicationofriskmanagementtomedicaldevices(ISO14971:2000).blankBS EN 13532:2002 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It is
