BS ISO 10555-6-2015 Intravascular catheters Sterile and single-use catheters Subcutaneous implanted ports《血管内导管 一次性使用无菌导管 皮下植入端口》.pdf

1、BSI Standards PublicationBS ISO 10555-6:2015Intravascular catheters Sterile and single-use cathetersPart 6: Subcutaneous implanted portsBS ISO 10555-6:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 10555-6:2015.The UK participation in its preparation was

2、entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The

3、 British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 78730 0ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 Ap

4、ril 2015.Amendments issued since publicationDate Text affectedBS ISO 10555-6:2015 ISO 2015Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted portsCathters intravasculaires Cathters striles et non rutilisables Partie 6: Chambres cathter implantablesINTERNATIONAL S

5、TANDARDISO10555-6First edition2015-04-15Reference numberISO 10555-6:2015(E)BS ISO 10555-6:2015ISO 10555-6:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in

6、 any form 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 ISOs member body in the country of the requester.ISO copyright officeCase post

7、ale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 10555-6:2015ISO 10555-6:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements of the implantable subcutaneous implanted por

8、t and catheter . 34.1 General . 34.2 Biocompatibility 44.3 Distance markings 44.4 Nominal dimensions of the subcutaneous implanted port 44.5 Physical requirements 44.5.1 Radio-detectability . 44.5.2 Surface finish . 44.5.3 Freedom from leakage 44.5.4 Flushing volume . 44.5.5 Characteristics of the s

9、eptum . 54.5.6 Characteristics of the connection or the catheter . 54.6 Flow rate . 54.6.1 Subcutaneous implanted ports not indicated for power injection . 54.6.2 Subcutaneous implanted ports indicated for power injection . 54.7 Burst pressure of the subcutaneous implanted port and catheter 64.7.1 S

10、ubcutaneous implanted ports not indicated for power injection . 64.7.2 Subcutaneous implanted ports indicated for power injection . 65 Magnetic Resonance Imaging (MRI) compatibility . 66 Information to be supplied by the manufacturer . 66.1 Marking on the device 66.2 Primary packaging . 66.3 Labels

11、for traceability . 76.4 Instruction for use 7Annex A (normative) Test method for freedom from air leakage 8Annex B (informative) Determination of flushing volume .10Annex C (informative) Guidance on further characterization testing: Needle penetration and withdrawal .12Annex D (normative) Test metho

12、d for freedom from leakage after multiple punctures .14Annex E (normative) Peak tensile force .15Bibliography .16 ISO 2015 All rights reserved iiiContents PageBS ISO 10555-6:2015ISO 10555-6:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national

13、standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International

14、 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for

15、 its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org

16、/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be i

17、n the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions re

18、lated to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 84, Devices for administration of medicinal prod

19、ucts and intravascular catheters.ISO 10555 consists of the following parts, under the general title Intravascular catheters Sterile and single-use catheters: Part 1: General requirements Part 3: Central venous catheters Part 4: Balloon dilatation catheters Part 5: Over-needle peripheral catheters Pa

20、rt 6: Subcutaneous implanted portsThe following part has been withdrawn and the content has been included in ISO 10555-1: Part 2: Angiographic cathetersiv ISO 2015 All rights reservedBS ISO 10555-6:2015Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports1 Sco

21、peThis part of ISO 10555 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.This part of ISO 10555 does not specify requirements, performance, and

22、user safety issues related to non-coring needles.NOTE Subcutaneous implanted ports are known to be used for indications other than intravascular such as intra-peritoneal, intra-thecal, intra-pleural, and epidural access.2 Normative referencesThe following documents, in whole or in part, are normativ

23、ely referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10555-1:2013, Intravascular catheters Sterile and single-use c

24、atheters Part 1: General requirementsISO 10555-3:2013, Intravascular catheters Sterile and single-use catheters Part 3: Central venous catheters3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 10555-1 and the following apply.3.1cathetersingle- or multi

25、ple-lumen tube allowing access to a point within the body at its distal end3.2connectionsystem connecting the catheter to the subcutaneous implanted port3.3effective surface areaarea available for puncture by the needle3.4flushing volumevolume of solution needed to fully replace one solution from th

26、e subcutaneous implanted port and catheter with anotherINTERNATIONAL STANDARD ISO 10555-6:2015(E) ISO 2015 All rights reserved 1BS ISO 10555-6:2015ISO 10555-6:2015(E)3.5non-coring needleneedle that does not produce a core when penetrating the septumNote 1 to entry: Core is a sliver of septum materia

27、l that can be produced when a needle perforates a septum.3.6outlet tubeexit cannula portion of the subcutaneous implanted port that is connected to the catheter3.7priming volumetotal amount of space available in the subcutaneous implanted port and catheter to be filled with solution3.8priming volume

28、 of the subcutaneous implanted portamount of space available in the subcutaneous implanted port to be filled with solution, where the space is comprised of both the reservoir and outlet tube3.9priming volume of the cathetertotal amount of space available in the effective length of the catheter to be

29、 filled with solution3.10reservoiropen space below the septum that receives the needle and is in communication with the outlet tube3.11septumself-sealing membrane through which the needle passes to communicate with the catheter3.12subcutaneous implanted portdevice which permits percutaneous access t

30、o the catheter2 ISO 2015 All rights reservedBS ISO 10555-6:2015ISO 10555-6:2015(E)Key1 septum2 effective surface area3 outlet tube4 reservoirFigure 1 Subcutaneous implanted portKey1 connection2 catheterFigure 2 Subcutaneous implanted port connected to a catheter4 Requirements of the implantable subc

31、utaneous implanted port and catheter4.1 GeneralUnless otherwise specified in this part of ISO 10555, the subcutaneous implanted port and catheter shall comply with ISO 10555-1. ISO 2015 All rights reserved 3BS ISO 10555-6:2015ISO 10555-6:2015(E)4.2 BiocompatibilitySubcutaneous implantable port shall

32、 be free from biological hazards.NOTE See ISO 10993-1 for the selection of appropriate test methods.4.3 Distance markingsIf the catheter is provided with distance markings, the marking shall be indicated as follows:a) for non-connected catheters, indicate distance from the distal end of the catheter

33、;b) for pre-connected catheters, indicate distance from the proximal end of the catheter.From the first mark, the distance between marks shall not exceed 5 cm.It is recommended that the distance marks be 1 cm apart on that portion of the catheter likely to be of importance to the user in positioning

34、 the catheter and monitoring catheter migration.4.4 Nominal dimensions of the subcutaneous implanted portIf provided, the following measurements shall be expressed in millimetres: subcutaneous implanted port dimensions; effective surface area of the septum, defined either as the diameter (in case of

35、 a circular septum) or as the length and width (in case of other shape) of the septum in nominal dimension.4.5 Physical requirements4.5.1 Radio-detectabilityThe radio-detectability shall comply with ISO 10555-1 and shall include the catheter, subcutaneous implanted port, and connection.4.5.2 Surface

36、 finishWhen examined by normal or corrected to normal vision, with a minimum x2,5 magnification, the surface of the subcutaneous implanted port shall appear free from extraneous matter.4.5.3 Freedom from leakageThe connection or any other part of the subcutaneous implanted port shall not leak air wh

37、en tested in accordance with the method given in Annex A.When the test is conducted according to Annex A, the subcutaneous implanted port is considered to leak if the reduction in pressure is greater than 2,65 kPa in 2 min or if a level of 200 kPa cannot be attained.The septum of the subcutaneous im

38、planted port shall not leak air when tested in accordance with the method given in Annex D.4.5.4 Flushing volumeThe manufacturer shall conduct characterization tests for the flushing volume. A test method is described in Annex B. Any other equivalent method may be used.4 ISO 2015 All rights reserved

39、BS ISO 10555-6:2015ISO 10555-6:2015(E)4.5.5 Characteristics of the septum4.5.5.1 Needle penetration and withdrawal forceIf tested in accordance with Annex C, the peak force of penetration and withdrawal of a non-coring needle recommended by the manufacturer should be determined.4.5.6 Characteristics

40、 of the connection or the catheter4.5.6.1 Peak tensile forceFor the connection between the port and the catheter, the minimum peak tensile force shall be 5 N when tested in accordance with Annex E.The minimum peak tensile force of all other parts of the catheter shall comply with ISO 10555-3:2013, 4

41、.4.4.6 Flow rateFor devices for which flow rate is defined, when tested in accordance with ISO 10555-1:2013, Annex E, the flow rate for each lumen shall be a minimum of 80 % of that stated by the manufacturer for catheters of nominal outside diameter less than 1,0 mm or a minimum of 90 % of that sta

42、ted by the manufacturer for catheters of nominal outside diameter equal to 1,0 mm or greater.If the flowrate through hydratable catheters is determined, it shall be determined in post-hydration states.4.6.1 Subcutaneous implanted ports not indicated for power injectionWhen tested in accordance with

43、the method given in ISO 10555-1:2013, Annex E, the following modifications shall be made to the test apparatus: the male 6 % (luer) taper fitting ISO 10555-1:2013, Figure E.1 component 6 shall be connected to the hub of a non-coring needle; the non-coring needle shall be placed through the septum of

44、 the subcutaneous implanted port; the subcutaneous implanted port shall be connected to the catheter under test (ISO 10555-1:2013, Figure E.1 component 7) following manufacturer instructions; an inline pressure transducer shall be connected to the proximal end of the non-coring needle.The test shall

45、 be completed with non-coring needles that characterize the minimum and maximum flow rate under gravity. The needle gauge and length shall be recorded.4.6.2 Subcutaneous implanted ports indicated for power injectionWhen tested in accordance with the method given in ISO 10555-1:2013, Annex G, the fol

46、lowing modifications shall be made to the test apparatus: the locking device (ISO 10555-1:2013, Figure G.1 component 4) shall be connected to the hub of a non-coring needle indicated for power injection; the non-coring needle shall be placed through the septum of the subcutaneous implanted port; the

47、 subcutaneous implanted port shall be connected to the catheter under test (ISO 10555-1:2013, Figure G.1, component 6) following manufacturer instructions. ISO 2015 All rights reserved 5BS ISO 10555-6:2015ISO 10555-6:2015(E)4.7 Burst pressure of the subcutaneous implanted port and catheterWhen teste

48、d in accordance with the method given in ISO 10555-1:2013, Annex F, the following modifications shall be made to the test apparatus: the locking device fitting (ISO 10555-1:2013, F.2.3 and Figure F.1 component 3) shall be connected to the hub of a non-coring needle according to the appropriate risk-

49、based clinical justification; the non-coring needle shall be placed through the septum of the subcutaneous implanted port; the subcutaneous implanted port shall be connected to the catheter under test (ISO 10555-1:2013, Figure F.1 component 5) following manufacturer instructions.4.7.1 Subcutaneous implanted ports not indicated for power injectionWhen tested in accordance with the method given in ISO 10555-1:2013, Annex F with the above modifications (see 4.7), the burst pressure shall exceed the peak pressure