医疗器械安全有效的基本要求清单英文版.docx
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医疗器械安全有效的基本要求清单英文版.docx
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医疗器械安全有效的基本要求清单英文版
3.Safeandeffectivebasicrequirementslistofmedicaldevices
Itemnumber
Requirement
Applicable
methodstoprovecompliance
Documentsthatprovideobjectiveevidence forcompliance
A
Generalprinciple
A1
Medicaldevicesshouldbedesignedandmanufacturedintheexpectedconditionsandpurposes,usedaccordingtotheexpectedusebyprospectiveusers,Ifapplicable,whoownthecorrespondingtechnicalknowledge,experience,educationbackground,training,medicalandhardwareconditions.Whenmedicaldevicesareused,thepotentialriskandbenefittothepatientsincomparisonshouldbeaccepted,andhighlevelofhealthandsafetyprotectionmethodsarenecessary.prospectiveusersprospectiveusers
Y
IEC60601-1
IEC60601-1-2
ISO14971
MEDDEV.2.7.1
EN1041
IEC62304
Testreport
Clinicalevaluationreport
Riskmanagementreport
-FMEA
Manual
-Caution
-Notice
Softwarevalidationreport
Label
A2
Medicaldevicesshouldbedesignedandmanufacturedfollowingthesafetyprincipleandgivenconsiderationtotheexistingtechnicalabilitytoensuretheresidualriskofeachhazardacceptableusingtheprinciplesbelow:
(1)Knownoranticipatedhazardshouldbeidentificated,andriskofexpecteduseandexpectedimproperuseshouldbeassessed.
(2)Riskduringmedicaldevices’designandproductionprocessesshouldbeeliminatedasfaraspossible.
(3)Thefullprotectionmeasuressuchasalarmshouldbeadoptedtoreducetheresidualriskasfaraspossible.
Y
IEC60601-1
IEC60601-1-2
EN60601-4
ISO14971
MEDDEV.2.7.1
EN1041
Testreport
Clinicalevaluationreport
Riskmanagementreport
-FMEA
Manual
-Caution
-Notice
label
(4)Theresidualriskshouldbeinformed.
A3
Medicaldevicesusedunderregulationsshouldbeuptoitsexpectedperformanceandneeditsscopeofapplication
Y
IEC60601-1
IEC60601-1-2
EN60601-4
MEDDEV.2.7.1
EN1041
Testreport
Clinicalevaluationreport
Softwarevalidationreport
Manual
A4
Thedegradationdegreeofmedicaldevicescharacteristicsandperformanceundertheconditionofnormaluseandmaintenanceshouldn’taffectitssafetyinitslifecycle.
Y
IEC60601-1
MEDDEV.2.7.1
ISO14971
Testreport
Clinicalevaluationreport
Riskmanagementreport
FMEA
A5
Medicaldevices’design,productionandpackagingshouldbeabletoguaranteethetransportationandstorageconditionsofthespecification,suchastemperatureandhumiditychanges,andwon’tmaketheadverseimpactofproductcharacteristicsandperformance.
Y
IEC60601-1-2
ISO14971
EN1041
ISO15223-1
Manual
-Transpirationandstorage
Riskmanagementreport
Testreport
-Transpirationandstorage
A6
Allrisksandunintendedeffectsshouldbeminimizedandbeacceptabletoensurethatbenefitsinnormaluseoutweightherisks.
Y
ISO14971
Riskmanagementreport
B
Thebasicprinciplesofsafetyandperformanceofmedicaldevices
B1
Chemical,physicalandbiologicalproperties
B1.1
ThematerialshouldbeabletoguaranteemedicaldevicesmeettherequirementsinpartA.Specialattention:
(1)Thetoxicity,flammabilityshouldbeespeciallyconsideredintheselectionofmaterials,ifapplicable.
N
Thisproductwillnotbeincontactwithpatientsdirectly.
(2)Thecompatibilityofthematerial,biologicaltissues,cellsandbodyfluidshouldbeconsideredbasedonthescopeofapplication.
(3)Thehardness,wearresistanceandfatiguestrengthpropertiesshouldbeconsideredinthematerialselection,ifapplicable.
B1.2
Medicaldevices’design,productionandpackagingshouldreducetheriskofthecontaminantsandresiduestopeopleengagedinthetransportation,storage,useandpatientsasfaraspossible.Specialattentionshouldbepaidtothecontacttimeandfrequencyofexposedtissueofhumanbodywiththeoutside.
Y
ISO14971
Riskmanagementreport
B1.3
Medicaldevices’designandproductionshouldbeabletoensuretheproductcanbeusedsafelywhencontactingothermaterials,substancesandgasinnormaluse.Ifmedicaldeviceswereforadministration,whosedesignandproductionshouldbeinconformitywiththerelevantprovisionsofthepharmaceuticalmanagement,andwhoseperformanceshouldn’tbechangedinthenormaluse
N
Thisproductwillnotbechangedperformancewhenitcontactswithothermaterial.
B1.4
Medicaldevices’designandproductionshouldreducetherisktheleachableorleakagecausedasfaraspossibleandspecialattentionshouldbepaidtoitscarcinogenic,teratogenicandreproductivetoxicity.
Y
IEC60601-1-2
Testreport
B1.5
Medicaldevices’designandproductionshouldconsiderthecharacteristicsofproductionanditsuseenvironmenttoreducetheriskofmaterial’sunexpectedentryandexittoproduct.
Y
ISO14971
IEC60601
Riskmanagementreport
Testreport
B2
Infectionandmicrobialcontamination
B2.1
Medicaldevices’designandproductionshouldreducetheriskofpatients,usersandothers’infection.Medicaldevices’designshould
(1)beofeasyoperation
(2)reducethemicrobialleakagefromproductsand/ormicrobialexposureinuseasmuchaspossible.
(3)preventmicrobialcontaminationofmedicalinstrumentsandsamplefrompeople.
N
Thisproductisirrelevanttoinfectionandmicrobiologycontaminationrisk.
B2.2
Medicaldevicesmarkedwiththemicrobiologicalrequirementsshouldbeincompliancewiththemicrobiologicalrequirementspriortouse.
N
Thisproducthasnorequirementsonmicrobiology.
B2.3
Sterilemedicaldevicesshallbeincompliancewiththeasepticrequirementspriortouse..
N
Thisproductisnotsterilemedicaldevice.
B2.4
Medicaldeviceswhicharesterileormarkedwithmicrobiologicalrequirementsshouldbeprocessed,manufacturedorsterilizedadoptingthemethodverified.
N
Thisproductisnotsterilemedicaldevice,andhasnorequirementsonmicrobiology.
B2.5
Sterilemedicaldevicesshallbeproducedinthecorrespondingcontrolstatesuchasthecorrespondinglevelofpurifyingtheenvironment.
N
Thisproductisnotsterilemedicaldevice.
B2.6
Nonsterilemedicaldevices’packagingshouldmaintainproducts’integrityandcleanliness.Thepackagingofproductsneedingtobesterilizedbeforeusingshouldreducemicrobialcontaminationoftheproductasfaraspossibleandshallbesuitableforcorrespondingsterilizationmethod.
N
Thisproduct’spackagingisnotneedtobesterilized.
B2.7
Ifmedicaldevicescanbelistedinbothsterileandnon-sterilestates,Theproductpackagingorlabelsshallbedistinguished.
N
Thisproductisnotsterilemedicaldevice.
B3
Medicineandmechanicalcombinationproduct
B3.1
Thesafety,qualityandperformanceofmedicineandmechanicalcombinationshouldbeverified.
N
Non-medicineandmechanicalcombinationproduct.
B4
Biogenicmedicaldevices
B4.1
Theanimalderivedtissues,cellsandmaterialwhicharecontainedinthemedicaldevicesshallcomplywiththerelevantregulations,andmeettherequirementsoftheapplicablescope.Sourcesofanimalsshallbekeptforfuturereference.Animaltissues,cellsandothermaterialprocessing,preservation,testingandhandlingprocessshouldprovidepatients,usersandothersifapplicable,withthebestsafetyprotection.Virusesandotherinfectioussourcesshalladoptthevalidatedremovalorinactivationtreatmentmethodespecially.
N
Notissueorcellfromanimalsintheproduct.
B4.2
Medicaldevicescontaininghumantissues,cellsandothersubstancesshouldchoosetheappropriatesource,donors,inordertoreducetheriskofinfection.Humantissues,cellsandothermaterialprocessing,preservation,testingandhandlingprocessshouldprovidepatients,usersandothersifapplicable,withthebestsafetyprotection.Virusesandotherinfectioussourcesshalladoptthevalidatedremovalorinactivationtreatmentmethodespecially.
N
Notissueorcellfromhumanbeingsintheproduct.
B4.3
Theprocessing,preservation,testingandhandlingprocessofmedicaldevicescontainingmicrobialcellsandothersubstances,cellandothermaterialshouldprovidepatients,usersandothersifapplicablewiththebestsafetyprotection.
N
Nomicrobialcellsintheproduct.
B5
Environmentalcharacteristics
B5.1
Ifmedicaldeviceswereusedcombinedwithothersexpectedly,thesafetyofwholesystemaftercombinationshallbeensuredandtheperformanceoftheapparatusorequipmentshouldn’tbeweakened.
Anylimitationsofcombinationuseshallbespecifiedonthelabeland/orinstructions.Liquid,gastransmissionormechanicalcouplingconnectionsystemshallreducethesafetyrisktousersthaterrorconnectioncausesfrombothdesignandstructureasmuchaspossible.
Y
IEC60601-1
ISO14971
MEDDEV.2.7.1
Manual
Testreport
Riskmanagementreport
Label
B5.2
B5.2.1
Medicaldevicesdesignandproductionshouldeliminateandreducetheserisksasfaraspossible,theriskstopatients,usersorotherscausedbythephysicalorergonomics.
Y
IEC60601-1
IEC60601-1-2
ISO14971
Manual
Riskmanagementreport
Testreport
B5.2.2
Thewrongoperationriskcausedbytheergonomics,humanfactorsandtheuseenvironment.
Y
IEC60601-1
IEC60601-1-2
ISO14971
Manual
Riskmanagementreport
Testreport
B5.2.3
Theriskassociatedwiththereasonableforeseeableexternalfactorsorenvironmentalconditions,suchasmagneticfield,electromagneticeffect,theexternalelectrostaticdischarge,radiationbroughtbydiagnosisandtreatment,pressure,humidity,temperature,pressureandaccelerationchange.
Y
IEC60601-1
IEC60601-1-2
ISO14971
IEC60068-2-6
ISO2248
Testreport
Riskmanagementreport
Manual
B5.2.4
Theriskcausedbypossible
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