111PTCA球囊扩张导管技术要求英文翻译.docx

111PTCA球囊扩张导管技术要求英文翻译.docx

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111PTCA球囊扩张导管技术要求英文翻译

11.1-PTCA球囊扩张导管技术要求英文翻译

11.1-PTCA球囊扩张导管技术要求英文翻译

Technicalrequirementsformedicaldeviceproductregistrationnumber：

DisposableSterilePTCAballooncatheter

1、Model/Specificationsanddivideinstructions

1、1Model

PTCA-XX-XX

BalloonWorkingLengthmm

BalloonnominalDiametermm

ProductNameCode

Modelmarkexample：

PTCA—2.0—10representsballoonnominalouterdiameteris2.0mmandworkinglengthis10mmofdisposableSterilePTCAballooncatheter

1、2Specifications

PTCAballooncatheterspecificationlist

Specifications

OD

Length

Theeffectivelengthofthecatheter

Maxguidewirediameter

Nominalpressure

RBP

DK-PTCA-1.5-10

1.50mm

10mm

142cm

≦0.014in

8ATM

16ATM

Radiopaqueringshouldbevisibleunderprovenimagingtechnologywhichintheclinicaluse.

2.3.4Tipconfiguration

Inordertoreducedamagetobloodvesselsduringtheuseprocess，theendoftipshouldbesmoothandhaveataperorthereisacertainprocessorviasimilarfinishing.

2.3.5Particulatepollution

Ballooncatheterproductionshouldundertheminparticulatepollutionconditions,innerandoutsurfaceofcathetershouldbecleanandpollutionindexshallcomplywiththerequirementsofGB8368-2005inChapter6.1.

2.3.6Non-hydratable

Changesofeffectivebeforeandafterhydrationshouldnotexceed4mmor1%higherthanbeforehydration（Takemin）；andmaxODchangesbeforeandafterhydrationshouldnotexceed10%ofmaxOD.

2.4Chemicalproperties

2.4.1Corrosionresistance

Shallcomplywiththerequirements4.4ofYY0285.1-2004.

2.4.2Reducingsubstance（Readilyoxidizablesubstance）

Thevolumedifferencebetweentestliquidandblankliquidconsumepotassiumpermanganatesolution[c（KmnO4）=0.002mol/l]shallnotexceed2.0ml.

2.4.3c

Thetotalcontentofbarium,chromium,copper,lead,tininthetestliquidshouldnotexceed1μg/ml,Cadmiumcontentshouldnotexceed0.1μg/ml.

2.4.4PH

ThedifferencebetweentestpHvalueandthecontrolofpHvalueshouldbelessthan1.5.

2.4.5Residualethyleneoxide

Residualethyleneoxideofballooncathetershouldnotmorethan10ug/g.

2.4.6Ballooncathetershouldbesterile.

2.4.7Ballooncatheterendotoxincontentshouldnotexceed2.15EUeach.

3.TestMethod

3.1Appearance

Withnormalorcorrectedvisionat2.5timesmagnificationinspection,Itshouldmeettherequirementsof2.1.

3.2Sizeandcolor

Withgeneralgaugefortesting,colorwithvisual.Itshouldmeettherequirementsof2.2.

3.3Physicalproperties

3.3.1Breakingforce

ThemethodaccordingtoYY0285.1-2004/giveninAppendixB,anditshallcomplywiththerequirementsof2.3.1.

3.3.2Leakage

a）ThemethodaccordingtoYY0285.1-2004giveninAppendixC,anditshallcomplywiththerequirementsof2.3.2a.

b）ThemethodaccordingtoYY0285.1-2004giveninAppendixD,anditshallcomplywiththerequirementsof2.3.2b.

3.3.3Raydetectability

Usinghospitalconventionalmethodtoperformfilm.

3.3.4Tipconfiguration

Withnormalorcorrectedvisionat2.5timesmagnificationinspection.

3.3.5Particulatepollution

ThemethodaccordingtoGB8368-2005giveninAppendixA.1chapter,theresultsshouldmeettherequirementsof2.3.5.

3.3.6Non-hydratable

AccordingtoYY0285.1-2004specifiedin3.9，immerseballooncatheterinto（37℃±1℃）twohoursandthenmeasurethesize,itshallcomplywiththerequirementsof2.3.6.

3.4Chemicalproperties

PreparationoftestsolutionaccordingtoGB/T14233.1-2008Chapter4.3,paragraph6atableintheprovisions。

3.4.1Corrosionresistance

CarriedoutaccordingtothemethodgiveninAppendixAofYY0285.1-2004,itshouldmeettherequirementsof2.4.1。

3.4.2Reducingsubstance（Readilyoxidizablesubstance）

TestinaccordancewithGB/T14233.1-2008provisionsofChapter5.2.2,itshallcomplywiththerequirementsof2.4.2.。

3.4.3Metalion

TestinaccordancewithGB/T14233.1-2008provisionsofChapter5.9.1,itshallcomplywiththerequirementsof2.4.3.

3.4.4PH

TestinaccordancewithGB/T14233.1-2008provisionsofChapter5.4.1,itshallcomplywiththerequirementsof2.4.4.

3.4.5Residualethyleneoxide

TestinaccordancewithGB/T14233.1-2008provisionsofChapter9,itshallcomplywiththerequirementsof2.4.5.

3.4.6Sterile

TestinaccordancewithGB/T14233.2-2005provisionsofChapter3,itshallcomplywiththerequirementsof2.4.6.

3.4.7Bacterialendotoxin

ExperimentsconductedinaccordancewithPartIV14233.2-2005recommendedtestmethods,itshallcomplywiththerequirementsof2.4.7.

4、Term

DuringtheusingprocessofdisposableSterilePTCAballooncatheter,First,transporttheguidewiretothelesionlocation,thenpenetratetheendofguidewirefromthetipandpierceoutfromguidewirelumen.ThenundertheX-rayimagetoobservetheradiopaqueringwhichalongtheguidewiredeliverythecatheter