1、 ISO 2013 Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors (IS-1) for implantable pacemakers Implants chirurgicaux Stimulateurs cardiaques Partie 3: Connecteurs bas profil (IS-1) pour stimulateurs implantables INTERNATIONAL STANDARD ISO 5841-3 Third edition 2013-04-15 Reference
2、 number ISO 5841-3:2013(E) ISO 5841-3:2013(E)ii ISO 2013 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including pho
3、tocopying, 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 office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749
4、09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO 5841-3:2013(E) ISO 2013 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Terms and definitions . 1 4 Requirements 2 4.1 General . 2 4.2 Lead connector . 3 4.3 Connector c
5、avity 4 Annex A (normative) Lead connector electrical impedance test method . 8 Annex B (informative) Rationale .10 ISO 5841-3:2013(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing I
6、nternational 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 organizations, governmental and non-governmental, in liaison
7、 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 its further maintenance are described in the ISO/IEC Direct
8、ives, 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. www.iso.org/directives Attention is drawn to the possibility that some of t
9、he 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 in the Introduction and/or on the ISO list of patent declarations
10、received. 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. The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. This third edition cancels
11、 and replaces the second edition (ISO 5841-3:2000), which has been technically revised. It also incorporates the Technical Corrigendum ISO 5841-3:2000/Cor 1:2003. ISO 5841 consists of the following parts, under the general title Implants for surgery Cardiac pacemakers: Part 2: Reporting of clinical
12、performance of populations of pulse generators or leads Part 3: Part 3: Low-profile connectors (IS-1) for implantable pacemakersiv ISO 2013 All rights reserved ISO 5841-3:2013(E) Introduction The development of this part of ISO 5841 was prompted by the concern of clinicians over the variety of appar
13、ently similar but incompatible pacing leads of the low-profile in-line type. (Because the major diameter of such leads is 3,2 mm, these connectors were frequently referred to as “3,2 mm” leads.) The purpose of this part of ISO 5841 is to specify a standard connector assembly, IS-1, to allow leads an
14、d pulse generators from different manufacturers to be interchangeable. The safety, reliability and function of a particular connector part are the responsibility of the manufacturer. Annex A gives a test method for lead connector impedance. Annex B provides a rationale: it is recommended that this a
15、nnex be read before using this part of ISO 5841 so that the user is informed about its limited objectives. ISO 2013 All rights reserved v Implants for surgery Cardiac pacemakers Part 3: Low-profile connectors (IS-1) for implantable pacemakers WARNING Do not use the connector cavity specified in this
16、 part of ISO 5841 if the implantable pulse generator is capable of introducing dangerous nonpacing signals (e.g. defibrillation signals) through an IS-1 connector (see 4.3.3). 1 Scope This part of ISO 5841 specifies a connector assembly to be used to connect implantable pacemaker leads to implantabl
17、e pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods. Other connector features such as fastening means and materials are not specified in this part of ISO 5841. This part of ISO 5841 is applicab
18、le only to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance or reliability of different leads and pulse generator assemblies. This part of ISO 5841 supplements ISO 14708-2 only for those pacemaker components which are claime
19、d by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirements in ISO 14708-2. NOTE Pacemaker connector assemblies not complying with this part of ISO 5841 may be safe and reliable and may have clinical advantages. 2 Normative references The following do
20、cuments, in whole or in part, are normatively 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 14708-2, Implants f
21、or surgery Active implantable medical devices Part 2: Cardiac pacemakers 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14708-2 and the following apply. 3.1 connector assembly assembly consisting of a lead connector and a connector cavity for the el
22、ectrical and mechanical connection of a lead to a pulse generator 3.2 lead connector that part of the connector assembly attached to a lead Note 1 to entry: See Figure 1. INTERNATIONAL ST ANDARD ISO 5841-3:2013(E) ISO 2013 All rights reserved 1 ISO 5841-3:2013(E) 3.3 connector cavity that part of th
23、e connector assembly attached to the pulse generator Note 1 to entry: See Figure 3. 3.4 sealing ring circumferential barrier intended to maintain the electrical insulation between electrically isolated parts of the connector assembly when implanted 3.5 seal zone surface in the connector cavity on wh
24、ich one or more sealing rings on the lead connector are intended to bear 3.6 connector cavity GO gauge tool for assessing the ability of a connector cavity to accept a lead connector of maximum size Note 1 to entry: See Figure 5. 3.7 lead connector GO gauge tool for assessing the ability of a lead c
25、onnector to be inserted into a connector cavity of minimum size Note 1 to entry: See Figure 2. 3.8 lead connector ring for a bipolar lead outermost conductive element of the lead connector intended to contact the outermost conductive element of the connector cavity 3.9 lead connector pin for a bipol
26、ar lead innermost conductive element of the lead connector intended to make electrical contact with the innermost conductive element of the connector cavity 3.10 lead connector pin for a unipolar lead conductive element of the lead connector intended to contact the innermost (or only) conductive ele
27、ment of the connector cavity 3.11 ring set screw set screw in a bipolar connector cavity which is intended to contact the lead connector ring 4 Requirements 4.1 General The test methods provided for the performance requirements that follow are type (qualification) tests. Equivalent test methods may
28、be used. However, in the event of a dispute, the test methods described in this part of ISO 5841 shall be used.2 ISO 2013 All rights reserved ISO 5841-3:2013(E) 4.2 Lead connector 4.2.1 Design requirements 4.2.1.1 Sealing rings At least one sealing ring shall be provided in each of two sealing-ring
29、zones on the lead connector and located as specified in Figure 1. Dimensions in millimetres Key 1 lead connector ring on bipolar leads a Optional tooling mark zone. b Optional index mark alignment zone. c Leading edge of first sealing ring of second seal set. d Sealing ring zone. Sealing rings as sh
30、own are for illustration only and are not restricted as to shape, size or number. e Centreline of first sealing ring of first seal set in its undeflected position. f If the section between datum A and datum B is rigid, these two diameters shall be concentric within 0,13 mm. g Zone in which the (3,1
31、0,3) mm diameter applies. h The diameter dimensions of the soft sections of the lead may be determined as the mean value of three measurements taken at locations oriented approximately 120 apart around the principal axis of the lead connector. i Break sharp corner. Figure 1 Lead connector 4.2.1.2 Di
32、mensions The lead connector shall have the dimensions specified in Figure 1. 4.2.1.3 Lead connector: Electrode continuity and function The lead connector pin shall be in electrical continuity with the stimulating electrode of the lead. ISO 2013 All rights reserved 3 ISO 5841-3:2013(E) The lead conne
33、ctor ring, if used, shall be in electrical continuity with an electrode having pacing and electrogram-sensing functions and which is other than the electrode that is in electrical continuity with the lead connector pin. 4.2.2 Performance requirements 4.2.2.1 Maximum insertion and withdrawal force of
34、 lead connector GO gauge As shipped, the lead connector shall fit completely into the lead connector GO gauge specified in Figure 2 with a maximum insertion and withdrawal force of 14 N and shall conform to the requirements of Figure 1. 4.2.2.2 Electrical impedance between conducting parts The minim
35、um electrical impedance between conductive elements intended to be electrically insulated by the sealing rings shall be 50 k. Compliance shall be determined by the test method described in Annex A. 4.2.2.3 Deformation due to set-screw forces Securing mechanism forces shall not deform the lead connec
36、tor to the extent that insertion and withdrawal forces are excessive. Compliance shall be determined as follows. Insert the lead connector into a connector cavity which conforms to Figure 3. Fasten the lead connector in the centre of zones 6 and 7 (see Figure 3) by two M2 set screws with cup point a
37、t a torque of 0,15 Nm 0,01 Nm. Then retract the set screws. The lead connector withdrawal force shall not exceed 14 N and shall comply with the insertion and withdrawal force requirement as specified in 4.2.2.1. 4.2.2.4 Effect on unipolar lead connector of ring set screw of bipolar connector cavity
38、The ring set screw shall not affect the function of a unipolar lead. Compliance shall be determined as follows. Carry out the test described in 4.2.2.3 and then check that the electrical function of the lead has not been affected by carrying out the tests described in 4.2.1.3 and 4.2.2.2. 4.2.3 Mark
39、ing Marking shall be permanent and legible. The lead connector shall be marked with the symbol “IS-1” as shown in Figure 4, with the size appropriate for the connector assembly part being marked. For unipolar lead connectors, each connector shall be marked with the letters “UNI”; for bipolar lead co
40、nnectors, each connector shall be marked with the letters “BI” as shown in Figure 4. An optional index mark may be provided as an alignment aid. If such a mark is provided, it shall be located in zone 3 as shown in Figure 3. 4.3 Connector cavity 4.3.1 Design requirements The connector cavity dimensi
41、ons shall be as specified in Figure 3. 4.3.2 Performance requirements 4.3.2.1 Insertion: Connector cavity GO gauge The connector cavity shall accept the GO gauge specified in Figure 5.4 ISO 2013 All rights reserved ISO 5841-3:2013(E) 4.3.2.2 Maximum insertion force: Gauge pin In the zone designated
42、as 5 in Figure 3, the cavity shall accept a gauge pin with a diameter of m m , with a finish not exceeding 0,4 m. The force required to insert the gauge pin shall not exceed 9 N. 4.3.3 Marking The pulse generator shall be marked with the symbol “IS-1” as shown in Figure 4, with the size appropriate
43、for the connector assembly part being marked. This marking shall not be applied if the pulse generator is capable of introducing dangerous nonpacing signals through an IS-1 lead connector. Dimensions in millimetres Key 1 vent hole Surface roughness on all bore diameters shall be Material: poly(methy
44、l methacrylate). Figure 2 Lead connector GO gauge ISO 2013 All rights reserved 5 ISO 5841-3:2013(E) Dimensions in millimetres Key a Stabilization zone 1. b Seal zone 2 for lead connector sealing rings. c Seal zone 3 for lead connector sealing rings. d When lead is locked in place, lead axis shall no
45、t be displaced from connector cavity centreline by more than 0,10 mm. e Zone 5 for gauge pin insertion force requirement. f Lead connector ring contact zone 6. (Diameter dimension does not apply to spring contacts.) g Lead connector pin contact zone 7. (Diameter dimension does not apply to spring co
46、ntacts.) h Break sharp corner. i Zone 2 only. j Zone 3 only. NOTE 1 The entry to the connector cavity should include a transition (i.e. chamfer, counterbore, etc.) in order to minimize seal distortion when inserting the lead connector into the connector cavity. NOTE 2 The minimum cavity depth of 5 m
47、m occurs when zone 2 is at the minimum tolerance and zone 1 is 2 mm. Figure 3 Connector cavity6 ISO 2013 All rights reserved ISO 5841-3:2013(E) Figure 4 Symbols/letters for designating connector assembly parts Dimensions in millimetres Key a Knurled. Figure 5 Connector cavity GO gauge ISO 2013 All r
48、ights reserved 7 ISO 5841-3:2013(E) Annex A (normative) Lead connector electrical impedance test method A.1 General This annex describes the test to be employed to determine compliance with 4.2.2.2. This is a type (qualification) test and is not intended to be used as a routine production test. The
49、manufacturer may use equivalent test methods. However, in case of dispute the following test method shall prevail. A.2 Specimen preparation Lead connectors for the test shall be in the condition as shipped to the customer. A.3 Reagent and materials A.3.1 Test cavity, simulating a connector cavity constructed in compliance with Figure A.1 with provision for offsetting the axis of the lead connector under test by 0,10 mm. A.3.2 Saline solution, approximately 9 g/l at 37 C 5 C.
