ISO 10555-6-2015 血管内导管--无菌型一次性使用导管一第6部分皮下植入式输液港

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INTERNATIONAL

STANDARD

ISO

10555-6

First edition

2015-04-15

Intravascular catheters—Sterile and

single-use catheters —

Part 6:

Subcutaneous implanted ports

Cathéters intravasculaires—Cathéters stériles et non réutilisables —

Partie 6:Chambres à cathéter implantables

Reference number

ISO 10555-6:2015(E)

◎ISO 2015

or by any means,electronic or mechanical,including photocopying,or posting on the internet or an intranet, without prior

written permission.Permission can be requested from either ISO at the address below or ISO's member body in the country of

the requester:

ISO copyright office

Case postale 56·CH-1211 Geneva 20

Tel.+41227490111

Fax+41227490947

E-mail copyright@iso.org

Web www.iso.org

Published in Switzerland

ISO 10555-6:2015(E)

Contents Page

Foreword ........................................................................................................................................................... iv

1 Scope....................................................................................................................................................... 1

2 Normative references........................................................................................................................... 1

3 Terms and definitions ...........................................................................................................................1

4 Requirements of the implantable subcutaneous implanted port and catheter.......................

4.1 General .........................................................................................................................................

4.2 Biocompatibility ....................................................................................................................... 4

4.3 Distance markings........................................................................................................................4

4.4 Nominal dimensions of the subcutaneous implanted por....................................................... 4

4.5 Physical requirements............................................................................................................... 4

4.5.1 Radio-detectability........................................................................................................4

4.5.2 Surface finish..................................................................................................................4

4.5.3 Freedom from leakage ............................................................................................... 4

4.5.4 Flushing volume........................................................................................................... 4

4.5.5 Characteristics of the septum...................................................................................... 5

4.5.6 Characteristics of the connection or the catheter.......................................................5

4.6 Flow rate.......................................................................................................................................

4.6.1 Subcutaneous implanted ports not indicated for power injection........................... 5

4.6.2 Subcutaneous implanted ports indicated for power injection...................................

4.7 Burst pressure of the subcutaneous implanted port and catheter..........................................6

4.7.1 Subcutaneous implanted ports not indicated for power injection...........................6

4.7.2 Subcutaneous implanted ports indicated for power injection...................................6

5 Magnetic Resonance Imaging(MRI) compatibility ....................................................................... 6

6 Information to be supplied by the manufacturer ........................................................................... 6

6.1 Marking on the device ............................................................................................................... 6

6.2 Primary packaging.......................................................................................................................6

6.3 Labels for traceability................................................................................................................... 7

6.4 Instruction for use....................................................................................................................... 7

Annex A(normative) Test method for freedom from air leakage........................................................... 8

Annex B(informative)Determination of flushing volume ....................................................................... 10

Annex C(informative) Guidance on further characterization testing: Needle penetration

and withdrawal ...................................................................................................................................12

Annex D(normative) Test method for freedom from leakage after multiple punctures .................. 14

Annex E(normative) Peak tensile force....................................................................................................... 15

Bibliography.......................................................................................................................................................16

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标签： #无菌 #ISO #血管内导管

摘要：

INTERNATIONALSTANDARDISO10555-6Firstedition2015-04-15Intravascularcatheters—Sterileandsingle-usecatheters—Part6:SubcutaneousimplantedportsCathétersintravasculaires—Cathétersstérilesetnonréutilisables—Partie6:ChambresàcathéterimplantablesReferencenumberISO10555-6:2015(E)ISO10555-6:2015(E)COPYRIGHTPRO...

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ISO 10555-6-2015 血管内导管--无菌型一次性使用导管一第6部分皮下植入式输液港

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