IEC6101021012002Particularrequirementsforinvitrodi

NORMEINTERNATIONALECEIIECINTERNATIONALSTANDARD61010-2-101PremièreéditionFirstedition2002-01Règlesdesécuritépourappareilsélectriquesdemesurage,derégulationetdelaboratoire–Partie2-101:Prescriptionsparticulièrespourlesappareilsmédicauxdediagnosticinvitro(DIV)Safetyrequirementsforelectricalequipmentformeasurement,controlandlaboratoryuse–Part2-101:Particularrequirementsforinvitrodiagnostic(IVD)medicalequipmentNuméroderéférenceReferencenumberCEI/IEC61010-2-101:2002PUBLICATIONGROUPÉEDESÉCURITÉGROUPEDSAFETYPUBLICATIONIEC:2002–3–CONTENTSFOREWORD...........................................................................................................................51Scopeandobject..............................................................................................................92Normativereferences.....................................................................................................113Termsanddefinitions.....................................................................................................114Tests..............................................................................................................................135MARKINGanddocumentation...........................................................................................156Protectionagainstelectricshock....................................................................................237ProtectionagainstmechanicalHAZARDS..........................................................................238Mechanicalresistancetoshockandimpact....................................................................239Protectionagainstthespreadoffire...............................................................................2510Equipmenttemperaturelimitsandresistancetoheat......................................................2511ProtectionagainstHAZARDSfromfluids...........................................................................2512Protectionagainstradiation,includinglasersources,andagainstsonicandultrasonicpressure.........................................................................................................2513Protectionagainstliberatedgases,explosionandimplosion...........................................2714Components...................................................................................................................2715Protectionbyinterlocks..................................................................................................2716Measuringcircuits..........................................................................................................27AnnexHIndexofdefinedterms..........................................................................................29AnnexAA(normative)Riskmanagement............................................................................31AnnexBB(normative)Instructionsforuseforself-testIVDmedicalequipment...................35Bibliography..........................................................................................................................43IEC:2002–5–INTERNATIONALELECTROTECHNICALCOMMISSION____________SAFETYREQUIREMENTSFORELECTRICALEQUIPMENTFORMEASUREMENT,CONTROLANDLABORATORYUSE–Part2-101:Particularrequirementsforinvitrodiagnostic(IVD)medicalequipmentFOREWORD1)TheIEC(InternationalElectrotechnicalCommission)isaworldwideorganizationforstandardizationcomprisingallnationalelectrotechnicalcommittees(IECNationalCommittees).TheobjectoftheIECistopromoteinternationalco-operationonallquestionsconcerningstandardizationintheelectricalandelectronicfields.Tothisendandinadditiontootheractivities,theIECpublishesInternationalStandards.Theirpreparationisentrustedtotechnicalcommittees;anyIECNationalCommitteeinterestedinthesubjectdealtwithmayparticipateinthispreparatorywork.International,governmentalandnon-governmentalorganizationsliaisingwiththeIECalsoparticipateinthispreparation.TheIECcollaboratescloselywiththeInternationalOrganizationforStandardization(ISO)inaccordancewithconditionsdeterminedbyagreementbetweenthetwoorganizations.2)TheformaldecisionsoragreementsoftheIEContechnicalmattersexpress,asnearlyaspossible,aninternationalconsensusofopinionontherelevantsubjectssinceeachtechnicalcommitteehasrepresentationfromallinterestedNationalCommittees.3)Thedocumentsproducedhavetheformofrecommendationsforinternationaluseandarepublishedintheformofstandards,technicalspecifications,technicalreportsorguidesandtheyareacceptedbytheNationalCommitteesinthatsense.4)Inordertopromoteinternationalunification,IECNationalCommitteesundertaketoapplyIECInternationalStandardstransparentlytothemaximumextentpossibleintheirnationalandregionalstandards.AnydivergencebetweentheIECStandardandthecorrespondingnationalorregionalstandardshallbeclearlyindicatedinthelatter.5)TheIECprovidesnomarkingproceduretoindicateitsapprovalandcannotberenderedresponsibleforanyequipmentdeclaredtobeinconformitywithoneofitsstandards.6)Attentionisdr