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Testing Capability Scope of Un-active Medical Devices-1
Publish time 2025-07-15 15:17
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| Plastics&polyetheretherketone(PEEK)polymersformedicaldevices | ||||||
| 1 | Plastics | 1 | Tensileproperties | Plastics—Determinationoftensileproperties—Part1:General principlesGB/T1040.1-2018 | ||
| Plastics—Determinationoftensileproperties—Part2:Test conditionsformouldingandextrusionplasticsGB/T1040.2-2022 | ||||||
| Plastics—Determinationoftensileproperties—Part3:Test conditionsforfilmsandsheetsGB/T1040.3-2006 | ||||||
| Plastics—Determinationoftensileproperties—Part1:General principlesISO527-1:2019 | ||||||
| Plastics—Determinationoftensileproperties—Part2:Test conditionsformouldingandextrusionplasticsISO527-2:2012 | ||||||
| Plastics—Determinationoftensileproperties—Part3:Test conditionsforfilmsandsheetsISO527-3:2018 | ||||||
| StandardtestmethodfortensilepropertiesofplasticsASTM D638-22 | ||||||
| 2 | Flexuralproperties | Plastics—DeterminationofflexuralpropertiesGB/T9341-2008 | ||||
| Plastics—DeterminationofflexuralpropertiesISO178:2019 | ||||||
| StandardTestMethodsforFlexuralPropertiesofUnreinforced andReinforcedPlasticsandElectricalInsulatingMaterials ASTMD790-17 | ||||||
| 3 | Impactstrength | Plastics—DeterminationofizodimpactstrengthGB/T1843-2008 | ||||
| Plastics—Determinationofcharpyimpactproperties—Part1: Non-instrumentedimpacttestGB/T1043.1-2008 | ||||||
| Plastics—DeterminationofCharpyimpactproperties—Part1: Non-instrumentedimpacttestISO179-1:2023 | ||||||
| Plastics—DeterminationofIzodimpactstrengthISO180:2023 | ||||||
| StandardtestmethodsfordeterminingtheIzodpendulumimpact resistanceofplasticsASTMD256-23ɛ1 | ||||||
| 4 | Compressive properties | Plastics—DeteminationofcompressivepropertiesGB/T1041- 2008 | ||||
| Plastics—DeterminationofcompressivepropertiesISO 604:2002 | ||||||
| StandardTestMethodforCompressivePropertiesofRigid PlasticsASTMD695-23 | ||||||
| 5 | Density | Testmethodsfordensityandrelativedensityoffiberreinforced plasticsGB/T1463-2005 | ||||
| Plastics—Methodsfordeterminingthedensityofnon-cellular plastics—Part1:Immersionmethod,liquidpycnometermethod andtitrationmethodISO1183-1:2019 | ||||||
| 6 | Ash | Plastics—Determinationofash—Part1:Generalmethods GB/T9345.1-2008 | ||||
| Plastics—Determinationofash—Part1:GeneralmethodsISO 3451-1:2019 | ||||||
| 7 | Swellratio | StandardTestMethodsforDeterminationofGelContentand SwellRatioofCrosslinkedEthylenePlasticsASTMD2765- 16(2024) | ||||
| 8 | Oxidationindex | StandardGuideforEvaluatingtheExtentofOxidationin PolyethyleneFabricatedFormsIntendedforSurgicalImplants ASTMF2102-17 | ||||
| 9 | Intrinsicviscosity | Plastics—Determinationoftheviscosityofpolymersindilute solutionusingcapillaryviscometer—part3:Polyethylenesand polypropylenesGB/T1632.3-2010 | ||||
| 10 | Glasstransition temperature | Plastics—Differentialscanningcalorimetry(DSC)—Part2: DeterminationofglasstransitiontemperatureGB/T19466.2- 2004 | ||||
| Plastics—Differentialscanningcalorimetry(DSC)—Part2: DeterminationofglasstransitiontemperatureandstepheightISO 11357-2:2020 | ||||||
| 11 | Temperatureand enthalpyofmelting andcrystallization | Plastics—Differentialscanningcalorimetry(DSC)—Part3: Determinationoftemperatureandenthalpyofmeltingand crystallizationGB/T19466.3-2004 | ||||
| Plastics—Differentialscanningcalorimetry(DSC)—Part3: Determinationoftemperatureandenthalpyofmeltingand crystallizationISO11357-3:2018 | ||||||
| 1 | Impactstrength | StandardSpecificationforUltra-High-Molecular-Weight PolyethylenePowderandFabricatedFormforSurgicalImplants ASTMF648-21AnnexesA1 | ||||
| 2 | Fusion,percent crystallinity,and meltingpoint | percentcrystallinity,andmeltingpoint Standardtestmethodformeasurement weightpolyethylenebymeansof calorimetryYY/T0815-2010 | ofenthalpyoffusion, differentialscanning ofultra-high-molecular | |||
| Implantsforsurgery—Ultra-high-molecular-weight Part4:Oxidationindexmethod | ||||||
| 2 | Ultra-High- Molecular- Weight Polyethylene forSurgical Implants | 3 | Oxidationindex | polyethylene— YY/T0772.4-2022 | ||
| Implantsforsurgery— polyethylene—Part4:Oxidation ISO5834-4:2019 | Ultra-high-molecular-weight indexmeasurementmethod | |||||
| 4 | Acceleratedageing | ImplantsforsurgeryUltra-high-molecular-weightpolyethylene Part3:AcceleratedageingmethodsYY/T0772.3-2009 | ||||
| Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part3:AcceleratedageingmethodsISO5834- 3:2019 | ||||||
| StandardPracticeforAcceleratedAgingofUltra-HighMolecular WeightPolyethyleneAfterGammaIrradiationinAirASTM F2003-02(2022) | ||||||
| 5 | Trans-Vinylene Yield | Standardtestmethodforevaluatingtrans-vinyleneyieldin irradiatedultra-high-molecular-weightpolyethylenefabricated formsintendedforsurgicalimplantsbyinfraredspectroscopy YY/T0814-2010 | ||||
| StandardTestMethodforEvaluatingTrans-VinyleneYieldin IrradiatedUltra-HighMolecularWeightPolyethyleneFabricated FormsIntendedforSurgicalImplantsbyInfraredSpectroscopy ASTMF2381-19 | ||||||
| 3 | Ultra-High- Molecular- Weight Polyethylene mouldedforms forSurgical Implants | 1 | Tensilestressat yield | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20167.4 | ||
| 2 | Tensilestressat break | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20167.5 | ||||
| 3 | Elongationatbreak | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20167.6 | ||||
| 4 | Tensileproperties | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsISO5834-2:2019 | ||||
| 5 | Notchedimpact strength | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20167.7 | ||||
| Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsISO5834-2:2019 | ||||||
| 6 | Density | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20166.1 | ||||
| Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsISO5834-2:2019 | ||||||
| 7 | Ash | Implantsforsurgery—Ultra-high-molecular-weight polyethylene—Part2:MouldedformsGB/T19701.2-20166.1 | ||||
| 4 | Polyetherether ketone(PEEK) polymersfor surgical implant | 1 | Infraredspectrum | Standardspecificationforpolyetheretherketone(PEEK)polymers forsurgicalimplantapplicationsYY/T0660-20085.1 | ||
| StandardSpecificationforPolyetheretherketone(PEEK) PolymersforSurgicalImplantApplicationsASTMF2026-235.2 | ||||||
| 2 | Tg、Tm、Tc | Standardspecificationforpolyetheretherketone(PEEK)polymers forsurgicalimplantapplicationsYY/T0660-20085.2 | ||||
| StandardSpecificationforPolyetheretherketone(PEEK) PolymersforSurgicalImplantApplicationsASTMF2026-235.3 | ||||||
| 3 | Totalheavymetals | Standardspecificationforpolyetheretherketone(PEEK)polymers forsurgicalimplantapplicationsYY/T0660-20085.2 | ||||
| StandardSpecificationforPolyetheretherketone(PEEK) PolymersforSurgicalImplantApplicationsASTMF2026-235.3 | ||||||
| 4 | Density | Standardspecificationforpolyetheretherketone(PEEK)polymers forsurgicalimplantapplicationsYY/T0660-20085.4 | ||||
| StandardSpecificationforPolyetheretherketone(PEEK) PolymersforSurgicalImplantApplicationsASTMF2026-235.5 | ||||||
| Metal | ||||||
| Metallicmaterials—Vickershardnesstest—Part1:Testmethod GB/T4340.1-2024 | ||||||
| 1 | Metal | 1 | Vickershardness | |||
| Metallicmaterials—Vickershardnesstest—Part1:Testmethod ISO6507-1:2023 | ||||||
| 2 | Theaveragegrain size | DeterminationofestimatingtheaveragegrainsizeofmetalGB/T 6394-20178.18.3 | ||||
| 3 | Tensileproperties | Metallicmaterials—Tensiletesting—Part1:Methodoftestat roomtemperatureGB/T228.1-2021 | ||||
| Metallicmaterials—Tensiletesting—Part1:Methodoftestat roomtemperatureISO6892-1:2019 | ||||||
| 4 | Compressive properties | Metallicmaterials—Compressiontestmethodatroom temperatureGB/T7314-2017 | ||||
| Metallicmaterials—Ductilitytesting—Compressiontestfor | ||||||
| porousandcellularmetalsGB/T31930-2015 | ||||||
| Mechanicaltestingofmetals—Ductilitytesting—Compression testforporousandcellularmetalsISO13314:2011 | ||||||
| Metallicmaterials—Brinellhardnesstest—Part1:Testmethod | ||||||
| 5 | Brinellhardness | GB/T231.1-2018 | ||||
| Metallicmaterials—Brinellhardnesstest—Part1:Testmethod ISO6506-1:2014 | ||||||
| 6 | Rockwellhardness | methodGB/T230.1-2018 hardnesstest—Part1：Test Metallicmaterials—Rockwell | ||||
| Metallicmaterials—Rockwellhardnesstest—Part1:Test methodISO6508-1:2023 | ||||||
| 7 | Microstructure | InspectionmethodsofmicrostructureformetalsGB/T13298- 2015 | ||||
| 8 | Hydrogen,oxygen,ni trogen,carbonand sulfur | Generalruleofchemicalanalysisfor hydrogen,oxygen,nitrogen,carbonandsulfurinmetallicmaterials GB/T14265-2017 | ||||
| 9 | Carbon,sulfur, nitrogen,and oxygen | StandardTestMethodsforDeterminationofCarbon,Sulfur, Nitrogen,andOxygeninSteel,Iron,Nickel,andCobaltAlloys byCombustionandInertGasFusionTechniquesASTME1019- 24 | ||||
| 2 | Steels | 1 | Theapparentgrain size | Steels—Micrographicdeterminationoftheapparentgrainsize ISO643:20247.17.2 | ||
| 2 | Contentof nonmetallic inclusions | Determinationofcontentofnonmetallicinclusionsinsteel— MicrographicmethodusingstandarddiagramsGB/T10561-2023 | ||||
| Steel—Determinationofcontentofnonmetallicinclusions— MicrographicmethodusingstandarddiagramsISO4967:2013 | ||||||
| 3 | Stainlesssteel | 1 | Chemical composition | Determinationofchemicalcompositioninstainlesssteel— Inductivelycoupledplasmaatomicemissionspectrometric methodSN/T2718-2010 | ||
| Determinationofmanganese,phosphorus,silicon,chromium, nickel,copper,molybdenum,andtitaniuminStainlesssteel— InductivelycoupledplasmaatomicemissionspectrometrySN/T | ||||||
| 2 | Flexuralstrength | Fineceramics(advancedceramics,advancedtechnicalceramics) —Testmethodforflexuralstrengthofmonolithicceramicsat roomtemperatureISO14704:2016 | ||||
| 3 | Fracturetoughness | Fineceramics(advancedceramics,advancedtechnicalceramics) —Testmethodforfracturetoughnessofmonolithicceramicsat roomtemperaturebysingleedgeprecrackedbeam(SEPB) methodISO15732:2003 | ||||
| 4 | Vickershardness | Fineceramics(advancedceramics,advancedtechnicalceramics) —Testmethodforhardnessofmonolithicceramicsatroom temperatureGB/T16534-2009 | ||||
| Fineceramics(advancedceramics,advancedtechnicalceramics) —Testmethodforhardnessofmonolithicceramicsatroom temperatureISO14705:2016 | ||||||
| 5 | Bendingfatigue | Testmethodforbendingfatigueoffineceramicsatroom temperatureGB/T43296-2023 | ||||
| Fineceramics(advancedceramics,advancedtechnicalceramics) —Testmethodforcyclicbendingfatigueofmonolithicceramics | ||||||
| atroomtemperatureISO22214:2006 | ||||||
| 6 | Acceleratedageing | ImplantsforSurgery—Ceramicmaterials—Part2:Composite materialsbasedonahighpurityaluminamatrixwithzirconia reinforcemenYY/T1294.2-2015 | ||||
| Implantsforsurgery—Ceramicmaterials—Part2:Composite materialsbasedonahigh-purityaluminamatrixwithzirconia reinforcementISO6474-2:2019 | ||||||
| 2 | Hydroxyapatite | 1 | Chemicalanalysis | Implantsforsurgery—Hydroxyapatite—Part1:Ceramic hydroxyapatiteGB/23101.1-20084.1 | ||
| Implantsforsurgery—Hydroxyapatite—Part2:Coatingsof hydroxyapatiteGB23101.2-20084.1 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase | ||||||
| purityGB23101.3-20234 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityISO13779-3:2018+Amd1:20214 | ||||||
| Implantsforsurgery—HydroxyapatitePart1:Ceramic hydroxyapatiteBSISO13779-1:20084.1 | ||||||
| 2 | Traceelements | Implantsforsurgery—Hydroxyapatite—Part1:Ceramic hydroxyapatiteGB/T23101.1-20084.2 | ||||
| Implantsforsurgery—Hydroxyapatite—Part2:Coatingsof hydroxyapatiteGB23101.2-20084.2 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-20224.3 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.3 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:20154.3 | ||||||
| Implantsforsurgery—HydroxyapatitePart1:Ceramic hydroxyapatiteBSISO13779-1:20084.2 | ||||||
| 3 | Crystallinityratio | Implantsforsurgery—Hydroxyapatite—Part1:Ceramic hydroxyapatiteGB23101.1-20084.3 | ||||
| Implantsforsurgery—Hydroxyapatite—Part2:Coatingsof hydroxyapatiteGB23101.2-20084.3 | ||||||
| Implantsforsurgery—HydroxyapatitePart1:Ceramic hydroxyapatiteBSISO13779-1:20084.3 | ||||||
| 4 | Crystallinity | Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.5 | ||||
| Implantsforsurgery—HydroxyapatitePart1:Ceramic | ||||||
| hydroxyapatiteBSISO13779-1:20084.4 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityGB/T23101.3-20235 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityISO13779-3:2018+Amd1:20215 | ||||||
| 5 | Mechanical properties— Compression strength | Implantsforsurgery—Hydroxyapatite—Part1:Ceramic hydroxyapatiteGB23101.1-20084.4 | ||||
| Implantsforsurgery—HydroxyapatitePart1:Ceramic hydroxyapatiteBSISO13779-1:20084.5 | ||||||
| 6 | Adhesionto substrate | Implantsforsurgery—Hydroxyapatite—Part2:Coatingsof hydroxyapatiteGB23101.2-20084.4 | Onlytest ≤100kN | |||
| 7 | Calciumto phosphorusmolar ratio(Ca/P) | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-20224.2 | ||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:20154.2 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.2 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityGB/T23101.3-20235 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityISO13779-3:2018+Amd1:20215 | ||||||
| 8 | Foreigncrystalline phases | Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.4 | ||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase | ||||||
| purityGB/T23101.3-20235 | ||||||
| Implantsforsurgery—Hydroxyapatite—Part3:Chemical analysisandcharacterizationofcrystallinityratioandphase purityISO13779-3:2018+Amd1:20215 | ||||||
| 9 | Morphology | Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.6 | ||||
| 10 | Coatingstrength | Implantsforsurgery—Hydroxyapatite—Part2:Thermally sprayedcoatingsofhydroxyapatiteISO13779-2:20185.7 | Onlytest ≤100kN | |||
| 11 | Coatingadhesion strength | Implantsforsurgery—Hydroxyapatite—Part4:Determination ofcoatingadhesionstrengthGB/T23101.4-2023 | Onlytest ≤100kN | |||
| Implantsforsurgery—Hydroxyapatite—Part4:Determination ofcoatingadhesionstrengthISO13779-4:2018 | Onlytest ≤100kN | |||||
| 12 | Qualitativeand quantitative determinationof foreignphases | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-20224.4 | ||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:20154.4 | ||||||
| 13 | Powdermorphology | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-20224.5 | ||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:20154.5 | ||||||
| 14 | Calcinationloss | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-20224.7 | ||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:20154.7 | ||||||
| 15 | Infrared spectroscopy | Implantsforsurgery—Hydroxyapatite—Part6:PowdersGB/T 23101.6-2022A3 | ||||
| Implantsforsurgery—Hydroxyapatite—Part6:PowdersISO 13779-6:2015A3 | ||||||
| № | TestObject | Item/Parameter | StandardorMethod | Note | ||
| № | Item/Parameter | |||||
| 4 | Totalheavymetals （Pb） | Standardspecificationforbeta-tricalciumphosphateforsurgical implantationYY/T0683-20083.4 | ||||
| SurgicalImplants | ||||||
| 1 | Porous coatingson medical implants | 1 | Averagecoating | Coatingsofsurgicalimplants—Part14:Stereologicalevaluation methodofporouscoatingsYY/T0988.14-20169.1 | ||
| thickness | StandardtestmethodforStereologicalEvaluationofPorous CoatingsonMedicalImplantsASTMF1854-159.1 | |||||
| 2 | VolumePercent Void | Coatingsofsurgicalimplants—Part14:Stereologicalevaluation methodofporouscoatingsYY/T0988.14-20169.2 | ||||
| StandardtestmethodforStereologicalEvaluationofPorous CoatingsonMedicalImplantsASTMF1854-159.2 | ||||||
| 3 | MeanVoid InterceptLength | Coatingsofsurgicalimplants—Part14:Stereologicalevaluation methodofporouscoatingsYY/T0988.14-20169.3 | ||||
| StandardtestmethodforStereologicalEvaluationofPorous CoatingsonMedicalImplantsASTMF1854-159.3 | ||||||
| 4 | Abrasionresistance ofcoatings | Coatingsofsurgicalimplants—Part15:Testmethordfor abrasionresistancetestingofmetallicthermalspraycoatings YY/T0988.15-2016 | ||||
| StandardTestMethodforMeasuringAbrasionResistanceof MetallicThermalSprayCoatingsbyUsingtheTaberAbraser ASTMF1978-22 | ||||||
| 5 | Tensileproperties | Coatingsofsurgicalimplants—Part11:Tensiontestingmethod ofcalciumphosphatecoatingandmetalliccoatingsYY/T 0988.11-2016 | Onlytest ≤100kN | |||
| StandardTestMethodforTensionTestingofCalciumPhosphate andMetallicCoatingsASTMF1147-24 | Onlytest ≤100kN | |||||
| 6 | Shear | Coatingsofsurgicalimplants—Part12:Sheartestingmethodof calciumphosphatecoatingandmetalliccoatingsYY/T0988.12- 2016 | Onlytest ≤100kN | |||
| StandardTestMethodforShearTestingofCalciumPhosphate CoatingsandMetallicCoatingsASTMF1044-05(2017)e1 | ||||||
| 7 | Shearfatigue | Coatingsofsurgicalimplants—Part13:Testmethodforshear andbendingfatiguetestingofcalciumphosphateandmetallic andcalciumphosphate/metalliccoatingYY/T0988.13-20164.1 | ||||
| StandardTestMethodforShearandBendingFatigueTestingof CalciumPhosphateandMetallicMedicalandComposite | ||||||
| CalciumPhosphate/MetallicCoatingsASTMF1160-14(2017)e1 | ||||||
| 8 | Coatingsthickness | Metallicandotherinorganiccoatings—Reviewofmethodsof measurementofthicknessGB/T6463-2005 | ||||
| Metallicandotherinorganiccoatings—Reviewofmethodsof measurementofthicknessISO3882:2024 | ||||||
| 9 | Fastnessofthe hydrophiliccoating | Intravascularcatheterandguidewire—Testingmethodfor fastnessofthehydrophiliccoatingYY/T1898-2024 | ||||
| 2 | Anodizing oxidelayerson titaniumand titaniumalloys | 1 | Hardness | Surgicalimplants—Anodizingoxidelayersontitaniumand titaniumalloys—GeneralrequirementsYY/T1615-20184.4.2 | ||
| 3 | Surgical implants | 1 | Roughness | GeometricalProductSpecifications(GPS)—Surface texture:Profilemethod—Rulesandproceduresfortheassessment ofsurfacetextureGB/T10610-2009 | ||
| Geometricalproductspecifications(GPS)—Surfacetexture: Profile—Part3:SpecificationoperatorsISO21920-3:2021 | ||||||
| 2 | Maximumtorque | Implantsforsportsmedicine—InterferencescrewYY/T1922- 20244.6.1 | ||||
| 3 | Insertiontorque | Implantsforsportsmedicine—InterferencescrewYY/T1922- 20244.6.2 | ||||
| 4 | Insertionforce | Implantsforsportsmedicine—InterferencescrewYY/T1922- 20244.6.3 | ||||
| 5 | Fixationstrength | Implantsforsportsmedicine—InterferencescrewYY/T1922- 20244.6.4 | ||||
| 6 | Fixationstrengthat multicycle | Implantsforsportsmedicine—InterferencescrewYY/T1922- 20244.6.5 | ||||
| 7 | Polymerandmetal | Wearofimplantmaterials—Polymerandmetalwearparticles —IsolationandcharacterizationYY/T0652-2016 | ||||
| wearparticles | Wearofimplantmaterials—Polymerandmetalwearparticles —IsolationandcharacterizationISO17853:2011 | |||||
| 8 | Lactidemonomer | Determinationoflactidemonomerresidualinpoly(lactide)for surgicalimplantsYY/T1776-2021 | ||||
| 9 | Cyclic potentiodynamic polarization | Standardtestmethodforconductingcyclicpotentiodynamic polarizationmeasurementstodeterminethecorrosion susceptibilityofsmallimplantdevicesYY/T0695-2008 | ||||
| StandardTestMethodforConductingCyclicPotentiodynamic PolarizationMeasurementstoDeterminetheCorrosion SusceptibilityofSmallImplantDevicesASTMF2129-24 | ||||||
| 10 | Open-circuit potential | Implantsforsurgery—Measurementsofopen-circuitpotentialto assesscorrosionbehaviourofmetallicimplantablematerialsand medicaldevicesoverextendedtimeperiodsYY/T1552-2017 | ||||
| Implantsforsurgery—Measurementsofopen-circuitpotentialto assesscorrosionbehaviourofmetallicimplantablematerialsand medicaldevicesoverextendedtimeperiodsISO16429:2004 | ||||||
| 11 | Galvaniccorrosion | Implantsforsurgery—Standardtestmethodforconductingand evaluatinggalvaniccorrosiontestsinelectrolytesYY/T1772- 2021 | ||||
| StandardTestMethodforEvaluatingthePotentialforGalvanic CorrosionforMedicalImplantsASTMF3044-20 | ||||||
| 12 | Pittingcorrosion potential | Implantsforsurgery—Measuringmethodforpittingcorrosion potentialonstainlessproductsYY/T1074-2002 | ||||
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| 4 | Boneplates | 1 | Bendingstrength andstiffness | Implantsforsurgery—Determinationofbendingstrengthand stiffnessofboneplatesYY/T0342-2020 | ||
| Standardspecificationandtestmethodformetallicboneplates ASTMF382-24AnnexesA1 | ||||||
| 2 | Implantsforsurgery—Testmethodfordeterminingthebending fatiguepropertiesofmetallicboneplatesYY/T1503-2016 | |||||
| Bendingfatigue | Standardspecificationandtestmethodformetallicboneplates ASTMF382-24AnnexesA2 | |||||
| 3 | Frettingcorrosion | Implantsforosteosynthesis—Standardtestmethodformeasuring frettingcorrosionofosteosynthesisplatesandscrewsYY/T 1655-2019 | ||||
| StandardTestMethodforMeasuringFrettingCorrosionof OsteosynthesisPlatesandScrewsASTMF897-19 | ||||||
| 5 | Metallicbone screws | 1 | Torsionalproperties | Standardspecificationandtestmethodsformetallicmedicalbone screwsASTMF543-23AnnexesA1 | ||
| 2 | Mechanical requirements | Implantsforsurgery—Metalbonescrewswithasymmetrical threadandsphericalunder-surface—Mechanicalrequirements andtestmethodsYY/T0662-2008 | ||||
| Implantsforsurgery—Metalbonescrewswithasymmetrical threadandsphericalunder-surface—Mechanicalrequirements andtestmethodsISO6475:1989 | ||||||
| 3 | Theaxialpullout strength | Implantsforsurgery—Testmethodfordeterminingtheaxial pulloutstrengthofmetallicbonescrewsYY/T1504-2016 | ||||
| Standardspecificationandtestmethodsformetallicmedicalbone screwsASTMF543-23AnnexesA3 | ||||||
| 4 | Drivingtorque | Implantsforsurgery—Testmethodfordrivingtorqueofmetallic bonescrewsYY/T1506-2016 | ||||
| Standardspecificationandtestmethodsformetallicmedicalbone screwsASTMF543-23AnnexesA2 | ||||||
| 5 | Self-tapping performance | Implantforsurgery—Testmethodfordeterminingtheself- tappingperformanceofmetallicbonescrewsYY/T1505-2016 | ||||
| Standardspecificationandtestmethodsformetallicmedicalbone screwsASTMF543-23AnnexesA4 | ||||||
| 6 | Hipjoint prostheses | 1 | Surfaceroughness ofjointsurface | Jointreplacementimplants——HipjointprosthesesYY0118- 20168.4.1 | ||
| 2 | Surfaceroughness | Implantsforsurgery——Partialandtotalhipjointprostheses— —Part2:Articulatingsurfacesmadeofmetallic，ceramicand plasticsmaterialsYY/T0809.2-20204.1.2 | ||||
| Implantsforsurgery——Partialandtotalhipjointprostheses— —Part2:Articulatingsurfacesmadeofmetallic,ceramicand plasticsmaterialsISO7206-2-2011/Amd.1:2016()E4.1.2 | ||||||
| 3 | Endurance propertiesand performanceof stemmedfemoral components | Implantsforsurgery——Partialandtotalhipjointprostheses— —Part4:Determinationofendurancepropertiesandperformance ofstemmedfemoralcomponentsYY/T0809.4-2018 | ||||
| Implantsforsurgery——Partialandtotalhipjointprostheses— —Part4:Determinationofendurancepropertiesandperformance ofstemmedfemoralcomponentsISO7206-4:2010+Amd1:2016 | ||||||
| 4 | Endurance propertiestesting andperformance requirementsof neckregionof stemmedfemoral components | Implantsforsurgery——Partialandtotalhipjointprostheses— —Part6:Endurancepropertiestestingandperformance requirementsofneckregionofstemmedfemoralcomponents YY/T0809.6-2018 | ||||
| Implantsforsurgery——Partialandtotalhipjointprostheses— —Part6:Endurancepropertiestestingandperformance requirementsofneckregionofstemmedfemoralcomponents ISO7206-6:2013（E） | ||||||
| 5 | Resistancetostatic load | Implantsforsurgery——Partialandtotalhipjointprostheses— —Part10:Determinationofresistancetostaticloadofmodular femoralheadsYY/T0809.10-20227.3 | ||||
| Implantsforsurgery--Partialandtotalhip-jointprostheses-- Part10:Determinationofresistancetostaticloadofmodular femoralheadsISO7206-10:20187.3 | ||||||
| 6 | Resistancetostatic | Implantsforsurgery——Partialandtotalhipjointprostheses— —Part10:Determinationofresistancetostaticloadofmodular femoralheadsYY/T0809.10-20227.4 | ||||
| load | Implantsforsurgery--Partialandtotalhip-jointprostheses-- Part10:Determinationofresistancetostaticloadofmodular femoralheadsISO7206-10:20187.4 | |||||
| 7 | Deformationtestfor acetabularshells | Implantsforsurgery—Partialandtotalhipjointprostheses—Part 12:DeformationtestmethodforacetabularshellsYY/T 0809.12-2020 | ||||
| Implantsforsurgery—Partialandtotalhipjointprostheses.Part 12:DeformationtestmethodforacetabularshellsISO7206- 12:2016 | ||||||
| 8 | Resistancetotorque ofheadfixationof stemmedfemoral components | Implantsforsurgery—Partialandtotalhipjointprostheses—Part 13:Determinationofresistancetotorqueofheadfixationof stemmedfemoralcomponentsYY/T0809.13-2020 | ||||
| Implantsforsurgery——Partialandtotalhipjointprostheses— —Part13:Determinationofresistancetotorqueofheadfixation ofstemmedfemoralcomponentsISO7206-13:2016 | ||||||
| 9 | TheAxialforces fordisasseular acetabulardevices | Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesYY/T1720-20208.2 | ||||
| Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesASTMF1820-228.2 | ||||||
| 10 | Offsetpulloutor leverout disassembly | Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesYY/T1720-20208.3 | ||||
| Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesASTMF1820-228.3 | ||||||
| 11 | Torqueout disassembly | Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesYY/T1720-20208.4 | ||||
| Standardtestmethodfordeterminingtheforcesfordisassembly ofmodularacetabulardevicesASTMF1820-228.4 | ||||||
| 12 | Fatiguestrengthof metallicacetabular shells | StandardTestMethodforFatigueTestingofAcetabularDevices forTotalHipReplacementASTMF3090-20 | ||||
| 13 | Testmethodforthe cyclicload-release bursttest | Implantsforsurgery—Determinationofimpactresistanceof ceramicfemoralheadsforhipjointprosthesesYY/T1705-2020 6.3 | ||||
| Implantsforsurgery—Determinationofimpactresistanceof ceramicfemoralheadsforhipjointprosthesesISO11491:2017 6.3 | ||||||
| 14 | Endurance propertiesof ceramicmodular femoralheads | Testmethodsforendurancepropertiesofceramicmodular femoralheadsYY/T1855-2022 | ||||
| StandardTestMethodsforDeterminationofCyclicFatigue StrengthofCeramicModularFemoralHeadsASTMF2345-21 | ||||||
| 7 | Kneejoint prostheses | 1 | Fatigueproperties | Implantsforsurgery——totalknee-jointprostheses——Part1: DeterminationofendurancepropertiesofkneetibialtraysYY/T 0810.1-2024 | ||
| Implantsforsurgery—totalknee-jointprostheses—Part1: DeterminationofendurancepropertiesofkneetibialtraysISO 14879-1:2020 | ||||||
| Standardpracticeforcyclicfatiguetestingofmetaltibialtray componentsoftotalkneejointreplacementsASTMF1800-19ɛ1 | ||||||
| 2 | Surfacefinish requirements | Implantsforsurgery—Componentsforpartialandtotalknee jointprostheses—Part2:Articulatingsurfacesmadeofmetal, ceramicandplasticsmaterialsYY/T0924.2-2024 | ||||
| Implantsforsurgery—Componentsforpartialandtotalknee jointprostheses—Part2:Articulatingsurfacesmadeofmetal, | ||||||
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| ceramicandplasticsmaterialsISO7207-2:2011+Amd2:2020 | ||||||
| 8 | Metallic lockable intramedullary nail | 1 | StaticFour-Point Bend | Implantsfororthosynthesis—Metalliclockableintramedullary nailYY/T0591-2011AnnexesA | ||
| StandardSpecificationandTestMethodsforIntramedullary FixationDevicesASTMF1264-24AnnexesA1 | ||||||
| 2 | TestMethodFor StaticTorsional TestingOf Intramedullary FixationDevices | Implantsfororthosynthesis—Metalliclockableintramedullary nailYY/T0591-2011AnnexesB | ||||
| StandardSpecificationandTestMethodsforIntramedullary FixationDevicesASTMF1264-24AnnexesA2 | ||||||
| 3 | Testmethodfor bendingfatigue testingof intramedullary fixation devicesbending fatigue | Implantsfororthosynthesis—Metalliclockableintramedullary nailYY/T0591-2011AnnexesCB | ||||
| StandardSpecificationandTestMethodsforIntramedullary FixationDevicesASTMF1264-24AnnexesA3 | ||||||
| 4 | Bendingfatigue strengthoflocking screws | Implantsfororthosynthesis—Metalliclockableintramedullary nailYY/T0591-2011AnnexesDB | ||||
| StandardSpecificationandTestMethodsforIntramedullary FixationDevicesASTMF1264-24AnnexesA4 | ||||||
| 9 | Metallicangled fixationdevice | 1 | Singlecompression bendingproperties | Implantsfororthosynthesis—Metallicangledfixationdevice YY/T0856-2011AnnexesA | ||
| 2 | Fatiguebending properties | Implantsfororthosynthesis—Metallicangledfixationdevice YY/T0856-2011AnnexesB | ||||
| 10 | Metallic fixationscrew forfemurneck | 1 | Maximumtorque andbreakingangle | Implantsforosteosynthesis—Metallicfixationscrewforfemur neckYY/T0346-20225.2.1 | ||
| 2 | Axialinsertstrength | Implantsforosteosynthesis—Metallicfixationscrewforfemur neckYY/T0346-20225.2.3 | ||||
| 3 | Axialpullout strength | Implantsforosteosynthesis—Metallicfixationscrewforfemur neckYY/T0346-20225.2.4 | ||||
| 4 | Staticcompression bendingproperties | Implantsforosteosynthesis—Metallicfixationscrewforfemur neckYY/T0346-20225.2.7 | ||||
| 5 | Fatiguecompression bendingproperties | Implantsforosteosynthesis—Metallicfixationscrewforfemur neckYY/T0346-20225.2.8 | ||||
| SpinalImplants | ||||||
| 1 | Intervertebral bodyfusion devices | 1 | StaticTests | Spinalimplants——Testmethodsformechanicalpropertyof intervertebralbodyfusiondevicesYY/T0959-20148 | ||
| Standardtestmethodsforintervertebralbodyfusiondevices ASTMF2077-228 | ||||||
| 2 | DynamicTests | Spinalimplants——Testmethodsformechanicalpropertyof intervertebralbodyfusiondevicesYY/T0959-20149 | ||||
| Standardtestmethodsforintervertebralbodyfusiondevices ASTMF2077-229 | ||||||
| 3 | Load-Induced SubsidenceUnder Staticaxial compression | Spinalimplants——Standardtestmethodformeasuringload inducedsubsidenceofintervertebralbodyfusiondeviceunder staticaxialcompressionYY/T0960-2014 | ||||
| Standardtestmethodformeasuringload-inducedsubsidenceof intervertebralbodyfusiondeviceunderstaticaxialcompression ASTMF2267-24 | ||||||
| 2 | Thespinal skeletalsystem | 1 | Statictest | Spinalimplants——Componentsusedinthesurgicalfixationof thespinalskeletalsystem——Part5:Testmethodformeasurethe staticandfatiguebendingstrengthofmetallicscrewsYY/T 0119.5-20148.1 | ||
| 2 | Fatiguetest | Spinalimplants——Componentsusedinthesurgicalfixationof thespinalskeletalsystem——Part5:Testmethodformeasurethe staticandfatiguebendingstrengthofmetallicscrewsYY/T 0119.5-20148.2 | ||||
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| 3 | Specificationfor metallicspinal screws | Standardspecificationsandtestmethodsforcomponentsusedin thesurgicalfixationofthespinalskeletalsystemASTMF2193- 20AnnexesA1 | ||||
| 4 | Specificationfor metallicspinalrods | Standardspecificationsandtestmethodsforcomponentsusedin thesurgicalfixationofthespinalskeletalsystemASTMF2193- 20AnnexesA3 | ||||
| 5 | Thestaticand dynamicbending propertiesof metallicspinal screws | Standardspecificationsandtestmethodsforcomponentsusedin thesurgicalfixationofthespinalskeletalsystemASTMF2193- 20AnnexesA4 | ||||
| 6 | Statictestingand fatiguetesting | Spinalimplants——Componentsusedinthesurgicalfixationof thespinalskeletalsystem——Part4:MetallicspinalrodsYY/T 0119.4-20145.2 | ||||
| 7 | DriveConnections | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part2:MetallicspinalscrewsYY/T 0119.2-20145.2 | ||||
| 8 | Torsionalproperties | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part2:MetallicspinalscrewsYY/T 0119.2-20145.3 | ||||
| 9 | Drivingtorque | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part2:MetallicspinalscrewsYY/T 0119.2-20145.4 | ||||
| 10 | TheAxialPullout Strength | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part2:MetallicspinalscrewsYY/T 0119.2-20145.5 | ||||
| 11 | Flexuralproperties | Spinalimplants—Componentsusedinthesurgicalfixationof thespinalskeletalsystem—Part2:MetallicspinalscrewsYY/T 0119.2-20145.6 | ||||
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| 3 | Torqueoffixation | WroughttitaniumandtitaniumdentalimplantYY0315-2023 5.6.1 | ||||
| Plasmasprayedhydroxyapatitecoatedtitaniumdentalimplant YY0304-20234.2.5.1 | ||||||
| 4 | WroughttitaniumandtitaniumdentalimplantYY0315-2023 5.6.2 | |||||
| Tighteningtorque | Plasmasprayedhydroxyapatitecoatedtitaniumdentalimplant YY0304-20234.2.5.2 | |||||
| 5 | Fatiguelimit | WroughttitaniumandtitaniumalloydentalimplantYY0315- 20235.6.3 | ||||
| Plasmasprayedhydroxyapatitecoatedtitaniumdentalimplant YY0304-20234.2.5.3 | ||||||
| 2 | Metallic materials | 1 | Staticimmersion test | Dentistry—CorrosiontestmethodsformetallicmaterialsYY/T 0528-20184.1 | ||
| Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.1 | ||||||
| 2 | Electrochemicaltest | Dentistry—CorrosiontestmethodsformetallicmaterialsYY/T 0528-20184.2 | ||||
| Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.2 | ||||||
| 3 | Sulfidetarnishtest (cyclicimmersion) | Dentistry—CorrosiontestmethodsformetallicmaterialsYY/T 0528-20184.3 | ||||
| Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.3 | ||||||
| 4 | Sulfidetarnishtest (staticimmersion) | Dentistry—CorrosiontestmethodsformetallicmaterialsYY/T 0528-20184.4 | ||||
| Dentistry—CorrosiontestmethodsformetallicmaterialsIS0 10271:20204.4 | ||||||
| 5 | Staticimmersion testwithperiodic | Dentistry—CorrosiontestmethodsformetallicmaterialsYY/T 0528-20184.5 | ||||
| 7 | Evaporationresidue | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.5 | ||||
| 8 | Totalheavymetals | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.6 | ||||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples | ||||||
| 821 | ||||||
| 9 | Ultraviolet adsorption | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.7 | ||||
| 10 | Ammonium | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.8 | ||||
| 11 | Partialheavymetals | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20225.9 | ||||
| 12 | Totalheavymetals inmaterials | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20226 | ||||
| 13 | Partialheavymetals inmaterials | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20227 | ||||
| 14 | Residueonignition | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20228 | ||||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples 0841 | ||||||
| № | TestObject | Item/Parameter | StandardorMethod | |||
| № | Item/Parameter | |||||
| 15 | Ethyleneoxide | Testmethodsforinfusion,transfusion,injectionequipmentsfor medicaluse—Part1:ChemicalanalysismethodsGB/T14233.1- 20229 | ||||
| Biologicalevaluationofmedicaldevices—Part7:Ethylene oxidesterilizationresidualsGB/T16886.7-2015 | ||||||
| Biologicalevaluationofmedicaldevices—Part7:Ethylene oxidesterilizationresidualsISO10993-7:2008 | ||||||
| 16 | Chloroethanol | Biologicalevaluationofmedicaldevices—Part7:Ethylene oxidesterilizationresidualsGB/T16886.7-2015 | ||||
| Biologicalevaluationofmedicaldevices—Part7:Ethylene oxidesterilizationresidualsISO10993-7:2008 | ||||||
| 17 | EDSanalysis | Microbeamanalysis—Quantitativeanalysisusingenergy- dispersivespectrometry(EDS)forelementswithanatomic numberof11(Na)oraboveGB/T17359-2023 | ||||
| Microbeamanalysis—Quantitativeanalysisusingenergy- dispersivespectrometry(EDS)forelementswithanatomic numberof11(Na)oraboveISO22309-2011 | ||||||
| 18 | Morphology analysis | Generalrulesofanalyticalmethodsforscanningelectron microscopeJY/T0584-2020 | ||||
| 19 | Infraredspectrum | GeneralrulesforinfraredanalysisGB/T6040-2019 | ||||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples 0402 | ||||||
| 20 | Organicanalysis | GeneralrulesofanalyticalmethodsforgaschromatographyJY/T 0574-2020 | ||||
| "Chinesepharmacopoeia"2020editionoffourgeneralprinciples 0521 | ||||||
| 21 | Identificationand quantificationof degradation | Biologicalevaluationofmedicaldevices—Part15: Identificationandquantificationofdegradationproductsfrom metalsandalloysGB/T16886.15-2022 | ||||
| productsfrom metalsandalloys | Biologicalevaluationofmedicaldevices—Part15: Identificationandquantificationofdegradationproductsfrom metalsandalloysISO10993-15:2019 | |||||
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