BS ISO 27186-2013 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements《有源可植入医疗器械 可植入心节律.pdf

1、BSI Standards PublicationBS ISO 27186:2010Active implantable medicaldevices Four-pole connectorsystem for implantable cardiacrhythm management devices Dimensional and testrequirementsBS ISO 27186:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 27186:2010.T

2、he UK participation in its preparation was entrusted to TechnicalCommittee CH/150/2, Cardiovascular implants.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

3、are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 65011 6ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theS

4、tandards Policy and Strategy Committee on 31 August 2013.Amendments issued since publicationDate Text affectedBS ISO 27186:2010Reference numberISO 27186:2010(E)ISO 2010INTERNATIONAL STANDARD ISO27186First edition2010-03-15Active implantable medical devices Four-pole connector system for implantable

5、cardiac rhythm management devices Dimensional and test requirements Dispositifs mdicaux actifs implantables Systmes de branchement quatre ples pour grer le rhythme cardiaque Dimensions et exigences dessai BS ISO 27186:2010ISO 27186:2010(E) PDF disclaimer This PDF file may contain embedded typefaces.

6、 In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing

7、Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized

8、for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2010 All rights reserved. Unless

9、otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copy

10、right office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 27186:2010ISO 27186:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Sc

11、ope1 2 Normative references1 3 Terms and definitions .2 4 Requirements.5 Annex A (normative) Electrical isolation test 22 Annex B (informative) Rationale for Annex A 27 Annex C (normative) Dielectric strength test.29 Annex D (informative) Rationale for Annex C 35 Annex E (normative) Current-carrying

12、 test high voltage types .39 Annex F (informative) Rationale for Annex E.44 Annex G (informative) Lead connector fatigue strength test.46 Annex H (informative) Lead connector seal zone materials.47 Annex I (informative) Seal zone creep 49 Annex J (informative) Contact resistance stability .54 Annex

13、K (informative) Rationale for Annex J.58 Annex L (informative) Selection of contact materials .60 Annex M (normative) Lead connector contact material requirements62 Annex N (informative) Rationale for Annex M66 Annex O (informative) Rationale for requirements in this International Standard.72 Annex

14、P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.) 79 Bibliography81 BS ISO 27186:2010ISO 27186:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member

15、 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 organizations, governmental

16、 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directiv

17、es, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies

18、casting a vote. 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. ISO 27186 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subco

19、mmittee SC 6, Active implants. BS ISO 27186:2010ISO 27186:2010(E) ISO 2010 All rights reserved vIntroduction The purpose of this International Standard is to specify a four-pole connector assembly to provide interchangeability between implantable leads and pulse generators for cardiac rhythm managem

20、ent from different manufacturers. The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. The four-pole connector was created to allow for a reduction in the number of individual lead connectors, reduce pocket bulk assoc

21、iated with existing bifurcated or trifurcated leads, reduce interaction of the lead bodies in the pocket and reduce set screw connections. This International Standard establishes two types of connector assembly: a “high voltage connector” and a “low voltage only connector”, each of which has several

22、 configurations. The high voltage connectors either have two low voltage contacts combined with one or two high voltage contacts, or they have only two high voltage contacts. The low voltage only connectors have either three or four low voltage contacts. The high voltage and low voltage only connect

23、ors and their voltage configurations are not intended to be interchangeable. This International Standard specifies a dimensional lockout feature that prevents the low voltage contacts of the lead connectors from contacting the high voltage contacts of high voltage connector cavities. BS ISO 27186:20

24、10BS ISO 27186:2010INTERNATIONAL STANDARD ISO 27186:2010(E) ISO 2010 All rights reserved 1Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements WARNING The low voltage only connector cavity specified in this

25、International Standard is not to be used if the implantable pulse generator is capable of introducing dangerous non-pacing stimuli (e.g. defibrillation shocks) through the contacts of that connector cavity. Likewise, the high voltage lead connector specified in this International Standard is not to

26、be used on leads intended for low voltage only therapy. 1 Scope This International Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requiremen

27、ts for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. This International Standard is not intended to replace or

28、 provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This International Standard is not applicable to high voltage systems with intended outputs greater than 1 000 V and/or 50 A. This International Standard is not applicable to sy

29、stems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This International Standard does not specify all connector features. It does not address all aspects of functional compatibility, safety or reliability o

30、f leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this International Standard might be safe and reliable, and might have clinical advantages. 2 Normative references The following referenced documents are indispensable for the appl

31、ication of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7436, Slotted set screws with cup point ASTM A276, Standard Specification for Stainless Steel Bars and Shapes

32、ASTM B348, Standard Specification for Titanium and Titanium Alloy Bars and Billets ASTM F562, Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications ASTM F746-04, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical

33、Implant Materials ASTM B896, Standard Test Methods for Evaluating Connectability Characteristics of Electrical Conductor Materials BS ISO 27186:2010ISO 27186:2010(E) 2 ISO 2010 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.

34、1 axial pin movement axial movement of a lead connector pin with reference to the lead connector body as present in some designs, particularly those with a rotating connector pin 3.2 bipolar having two poles or electrodes NOTE See also tripolar (3.31), integrated bipolar (3.15), and four-pole (3.8).

35、 3.3 connector system assembly consisting of a lead connector and a connector cavity that are electrically and mechanically joined 3.4 connector cavity cavity within the pulse generator which is intended to receive a lead connector 3.5 contact mechanism conductive hardware within the connector cavit

36、y provided for making electrical connection to corresponding contacts on a lead connector 3.6 distal farthest from a point of reference NOTE The point of reference for a lead is the lead connector pin. Therefore, the most distal electrode of a lead is the electrode that is farthest from the lead con

37、nector pin. See also proximal (3.26). 3.7 fixation zone zone located on the lead connector pin and within the connector cavity where the lead connector is mechanically secured within the connector cavity 3.8 four-pole having four poles or electrodes NOTE Generally a four-pole ICD lead has two low vo

38、ltage electrodes and two high voltage electrodes. A four-pole low voltage only lead has four low voltage electrodes. See also bipolar (3.2) and tripolar (3.31). 3.9 functional contact zone zone in the connector cavity which defines a site where electrical contact with a lead connector is to occur 3.

39、10 functional seal zone zone within the connector cavity which defines a site where sealing contact with a lead connector is to occur 3.11 grip zone area of the lead connector which is provided for grasping during insertion and withdrawal of the lead connector from the connector cavity BS ISO 27186:

40、2010ISO 27186:2010(E) ISO 2010 All rights reserved 33.12 high voltage electrical potentials greater than 20 V up to 1 000 V NOTE High voltages are generally used for defibrillating the heart. 3.13 high voltage connector lead connector or connector cavity that has high voltage contacts NOTE A high vo

41、ltage connector may also contain low voltage contacts. See also low voltage only connector (3.22). 3.14 insertion indicator zone zone on the pin of the lead connector allocated for manufacturers to provide a visual indicator for use in verifying full insertion of a lead connector into a connector ca

42、vity 3.15 integrated bipolar having two lead poles or lead electrodes that are electrically common NOTE A typical integrated bipolar ICD lead has a distal shock electrode that doubles as a proximal pace/sense ring electrode and is electrically attached to two separate lead connector contacts. 3.16 l

43、ead connector part of a lead that is intended for insertion into the connector cavity of a pulse generator 3.17 lead connector contacts conductive elements on the lead connector which include the lead connector pin and lead connector rings 3.18 lead connector pin most proximal conductive element of

44、a lead connector provided for making electrical contact as well as for securing the lead connector within the connector cavity 3.19 lead connector ring annular conductive elements on the lead connector intended for making electrical contact within the connector cavity NOTE The four-pole connector ha

45、s three lead connector rings and a lead connector pin. 3.20 lead electrode distal part of a lead through which electrical impulses are transmitted to or from cardiac tissue NOTE High voltage electrodes are capable of delivering high voltage electrical impulses. Low voltage electrodes are used for tr

46、ansmitting and sensing low voltage impulses and are generally not suitable for delivering high voltage. 3.21 low voltage electrical potential less than or equal to 20 volts NOTE Low voltage is generally used for pacing and sensing the heart. See also high voltage (3.12). BS ISO 27186:2010ISO 27186:2

47、010(E) 4 ISO 2010 All rights reserved3.22 low voltage only connector lead connector or connector cavity that has only low voltage contacts NOTE See also high voltage connector (3.13). 3.23 pin visibility zone zone within the connector cavity which is allocated for visual verification that the lead c

48、onnector is fully inserted NOTE It corresponds to the insertion indicator zone of the lead connector. 3.24 pristine contact zone zone on the lead connector which defines the minimum surface required for making electrical contact with the mating contact in the connector cavity NOTE The pristine conta

49、ct zones of the lead connector align with the functional contact zones of the connector cavity when the connectors are mated. 3.25 pristine seal zone zone on the lead connector which defines the minimum surface required for sealing with the mating seals in the connector cavity NOTE The pristine seal zones of the lead connector align with the functional seal zones of the connector cavity when the connectors are mated. 3.26 proximal nearest to a point of reference NOTE The point of reference for a lead is the lead connector pin. T