IEC 61010-2-101-2002 Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61010-2-101-2002 Particular requirements for in vitro diagnostic (IVD) medical equipment

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1、NORMECEIINTERNATIONALEIECINTERNATIONAL61010-2-101STANDARDPremièreéditionFirstedition2002-01PUBLICATIONGROUPÉEDESÉCURITÉGROUPEDSAFETYPUBLICATIONRèglesdesécuritépourappareilsélectriquesdemesurage,derégulationetdelaboratoire–Partie2-101:Prescriptionsparticulièrespourlesappareilsmédicauxde

2、diagnosticinvitro(DIV)Safetyrequirementsforelectricalequipmentformeasurement,controlandlaboratoryuse–Part2-101:Particularrequirementsforinvitrodiagnostic(IVD)medicalequipmentNuméroderéférenceReferencenumberCEI/IEC61010-2-101:200261010-2-101ÓIEC:2002–3–CONTENTSFOREWORD..................

3、.........................................................................................................51Scopeandobject..............................................................................................................92Normativereferences..................................

4、...................................................................113Termsanddefinitions.....................................................................................................114Tests........................................................................................

5、......................................135MARKINGanddocumentation...........................................................................................156Protectionagainstelectricshock....................................................................................237Protectiona

6、gainstmechanicalHAZARDS..........................................................................238Mechanicalresistancetoshockandimpact....................................................................239Protectionagainstthespreadoffire...............................................

7、................................2510Equipmenttemperaturelimitsandresistancetoheat......................................................2511ProtectionagainstHAZARDSfromfluids...........................................................................2512Protectionagainstradiation,inclu

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