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Testing Capability Scope of Un-active Medical Devices-2
Publish time 2025-07-15 15:38
| № | TestObject | Item/Parameter | StandardorMethod | ||
| № | Item/Parameter | ||||
| 3343-2012 | |||||
| 2 | Corrosionresistance | Medicalinstrumentsofstainlesssteel—Testmethodsof corrosionresistanceYY/T0149-2006 | |||
| 1 | Chemical composition | StandardSpecificationforWroughtNickel-TitaniumShape MemoryAlloysforMedicalDevicesandSurgicalImplants ASTMF2063-187 | |||
| StandardTestMethodforDeterminationofHydrogeninReactive MetalsandReactiveMetalAlloysbyInertGasFusionwith | |||||
| 4 | Titaniumand titaniumalloys | 2 | Hydrogen | DetectionbyThermalConductivityorInfraredSpectrometry ASTME1447-22 | |
| 3 | Transformation Temperature | Standardtestmethodfortransformationtemperatureofnickel— TitaniumalloysbythermalanalysisYY/T0641-2008 | |||
| StandardSpecificationforWroughtNickel-TitaniumShape MemoryAlloysforMedicalDevicesandSurgicalImplants ASTMF2063-188 | |||||
| StandardTestMethodforTransformationTemperatureof Nickel-TitaniumAlloysbyThermalAnalysisASTMF2004-24 | |||||
| 4 | Microstructure | StandardSpecificationforWroughtNickel-TitaniumShape MemoryAlloysforMedicalDevicesandSurgicalImplants ASTMF2063-189.1 | |||
| 5 | Microcleanliness | StandardSpecificationforWroughtNickel-TitaniumShape MemoryAlloysforMedicalDevicesandSurgicalImplants ASTMF2063-189.2 | |||
| 6 | Mechanical Property | StandardSpecificationforWroughtNickel-TitaniumShape MemoryAlloysforMedicalDevicesandSurgicalImplants ASTMF2063-1810 | |||
| 7 | Tensileproperties | StandardTestMethodforTensionTestingofNickel-Titanium SuperelasticMaterialsASTMF2516-22 | |||
| 8 | Nickelionrelease | Cardiovascularimplants—Standardtestmethodfornickelion | |||
| № | TestObject | Item/Parameter | StandardorMethod | ||
| № | Item/Parameter | ||||
| releaseofnickel-titaniumalloyYY/T1823-2022 | |||||
| 9 | Chemical | WroughttitaniumandtitaniumalloyforsurgicalimplantsGB/T 13810-20173.2 | |||
| Designationandcompositionoftitaniumandtitaniumalloys GB/T3620.1-20163 | |||||
| composition | Methodforchemicalanalysisoftitaniumsponge,titaniumand titaniumalloys—Determinationofmultielementcontent— InductivelycoupledplasmaatomicemissionspectrometryYS/T 1262-2018 | ||||
| 10 | Oxygenand nitrogencontent | Methodsforchemicalanalysisoftitaniumsponge,titaniumand titaniumalloys—Determinationofoxygenandnitrogencontent GB/T4698.7-2011 | |||
| 11 | Hydrogencontent | Methodsforchemicalanalysisoftitaniumsponge,titaniumand titaniumalloys—DeterminationofhydrogencontentGB/T 4698.15-2011 | |||
| Methodsforchemicalanalysisoftitaniumsponge,titaniumand | |||||
| 12 | Carboncontent | titaniumalloys—DeterminationofcarboncontentGB/T 4698.14-2011 | |||
| 13 | Microstructureand macrostructure | Microstructureandmacrostructureexaminationfortitaniumand titaniumalloysGB/T5168-2020 | |||
| 14 | Surface contaminationlayer | Testmethodoftitaniumandtitaniumalloysurfacecontamination layerGB/T23603-2009 | |||
| InorganicMaterialsformedicaldevices | |||||
| 1 | Ceramics | 1 | Density | Fineceramics(advancedceramics,advancedtechnicalceramics) —DeterminationofdensityandapparentporosityISO 18754:2020 | |
| 2 | Grainsize | Fineceramics(advancedceramics,advancedtechnicalceramics) —Microstructuralcharacterization—Part1:Determinationof grainsizeandsizedistributionISO13383-1:2012 | |||
| № | TestObject | Item/Parameter | StandardorMethod | ||
| № | Item/Parameter | ||||
| analysis | Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.5 | ||||
| 6 | Crevicecorrosion | Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.7 | |||
| MedicalDevice | |||||
| 1 | Medical Device | 1 | Preparationof testingliquids | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20224.2 | |
| 2 | Clarity | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.1.1 | |||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples 0902 | |||||
| 3 | Color | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.1.2 | |||
| "Chinese principles | |||||
| 4 | Reducing substances | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.2 | |||
| 5 | Chloride | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.3 | |||
| 6 | pHvalue | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.4 | |||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples 0631 | |||||
| № | TestObject | Item/Parameter | StandardorMethod | ||
| № | Item/Parameter | ||||
| 12 | Statictestingand fatiguetesting | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part3:MetallicspinalplatesYY/T 0119.3-20145.2 | |||
| StandardSpecificationsandTestMethodsforComponentsUsed intheSurgicalFixationoftheSpinalSkeletalSystemASTM F2193-20AnnexesA2 | |||||
| 13 | Staticproperties | Standardguideforevaluatingthestaticandfatiguepropertiesof interconnectionmechanismsandsubassembliesusedinspinal arthrodesisimplantsYY/T0961-20148 | |||
| StandardTestMethodforEvaluatingtheStaticandFatigue PropertiesofInterconnectionMechanismsandSubassemblies UsedinSpinalArthrodesisImplantsASTMF1798-218 | |||||
| 14 | Fatigueproperties | Standardguideforevaluatingthestaticandfatiguepropertiesof interconnectionmechanismsandsubassembliesusedinspinal arthrodesisimplantsYY/T0961-20149 | |||
| StandardTestMethodforEvaluatingtheStaticandFatigue PropertiesofInterconnectionMechanismsandSubassemblies UsedinSpinalArthrodesisImplantsASTMF1798-219 | |||||
| 3 | Spinalimplant | 1 | Fatiguetesting | Standardtest vertebrectomy | methodsforspinalimplant modelYY/T0857-20118.2 |
| Standardtest vertebrectomy | methodsforspinalimplant modelASTMF1717-218.2 | ||||
| DentalImplantsMaterialsandDevices | |||||
| 1 | Dentalimplant | 1 | Dynamicfatigue testing | Dentistry——Implants——Dynamicfatiguetestforendosseous dentalimplantsYY/T0521-2018 | |
| Dentistry——Implants——Dynamicloadingtestforendosseous dentalimplantsISO14801:2016 | |||||
| 2 | Statictorsional | Dentistry——Torsiontestofimplantbody/connectingpartjoints ofendosseousdentalimplantsystemsISO/TS13498:2011(E) | |||
| № | TestObject | Item/Parameter | StandardorMethod | ||
| № | Item/Parameter | ||||
| 16 | Dissolution | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-2022A7 | |||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:2015A7 | |||||
| 17 | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-2022A8 | ||||
| Solubilityproduct | Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:2015A8 | ||||
| 3 | Calcium phosphate | 1 | Dissolution | Implantsforsurgery—Standardtestmethodfordissolution testingofcalciumphosphategranules,fabricatedformsand coatingsYY/T1640-2018 | |
| StandardTestMethodforDissolutionTestingofCalcium PhosphateGranules,FabricatedForms,andCoatingsASTM F1926/F1926M-14(2021) | |||||
| 4 | Beta-tricalcium phosphate | 1 | Calciumand phosphoruscontent | Standardspecificationforbeta-tricalciumphosphateforsurgical implantationYY/T0683-20083.1 | |
| StandardSpecificationforMedical-GradeBeta-Tricalcium PhosphateRawMaterialforImplantableMedicalDevicesASTM F1088-23 | |||||
| 2 | Beta-tricalcium phosphatecontent | Standardspecificationforbeta-tricalciumphosphateforsurgical implantationYY/T0683-20083.2 | |||
| StandardSpecificationforMedical-GradeBeta-Tricalcium PhosphateRawMaterialforImplantableMedicalDevicesASTM F1088-23 | |||||
| 3 | Elemental Impurities | Standardspecificationforbeta-tricalciumphosphateforsurgical implantationYY/T0683-20083.3 | |||
| StandardSpecificationforMedical-GradeBeta-Tricalcium PhosphateRawMaterialforImplantableMedicalDevicesASTM F1088-23 | |||||
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