1、 Reference number ISO 27186:2010(E) ISO 2010INTERNATIONAL STANDARD ISO 27186 First edition 2010-03-15 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements Dispositifs mdicaux actifs implantables Systmes de b
2、ranchement quatre ples pour grer le rhythme cardiaque Dimensions et exigences dessai ISO 27186:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are em
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7、shed in Switzerland ii ISO 2010 All rights reservedISO 27186:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 Requirements.5 Annex A (normative) Electrical isolation test 22 Annex B (informative) Rationale
8、for Annex A 27 Annex C (normative) Dielectric strength test.29 Annex D (informative) Rationale for Annex C 35 Annex E (normative) Current-carrying test high voltage types .39 Annex F (informative) Rationale for Annex E.44 Annex G (informative) Lead connector fatigue strength test.46 Annex H (informa
9、tive) Lead connector seal zone materials.47 Annex I (informative) Seal zone creep 49 Annex J (informative) Contact resistance stability .54 Annex K (informative) Rationale for Annex J.58 Annex L (informative) Selection of contact materials .60 Annex M (normative) Lead connector contact material requ
10、irements62 Annex N (informative) Rationale for Annex M66 Annex O (informative) Rationale for requirements in this International Standard.72 Annex P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.) 79 Bibliography81 ISO 27186:2010(E) iv ISO 2010 All rights reservedFor
11、eword ISO (the International Organization for Standardization) is a worldwide federation of national 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 tech
12、nical committee has been established has the right to be represented on that committee. International 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
13、 electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated t
14、o the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies 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
15、 identifying any or all such patent rights. ISO 27186 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. ISO 27186:2010(E) ISO 2010 All rights reserved vIntroduction The purpose of this International Standard is to specify a four-pole connector
16、assembly to provide interchangeability between implantable leads and pulse generators for cardiac rhythm management from different manufacturers. The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. The four-pole conn
17、ector was created to allow for a reduction in the number of individual lead connectors, reduce pocket bulk associated 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
18、 of connector assembly: a “high voltage connector” and a “low voltage only connector”, each of which has several 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 volta
19、ge only connectors have either three or four low voltage contacts. The high voltage and low voltage only connectors 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 t
20、he lead connectors from contacting the high voltage contacts of high voltage connector cavities. INTERNATIONAL 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
21、 requirements WARNING The low voltage only connector cavity specified in this 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 h
22、igh voltage lead connector specified in this International Standard is not to 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 an
23、d/or defibrillation functions. This International Standard includes requirements 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 appro
24、priate test methods. This International Standard is not intended to replace or 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
25、 than 1 000 V and/or 50 A. This International Standard is not applicable to systems 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 doe
26、s not address all aspects of functional compatibility, safety or reliability of 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 Normativ
27、e references The following referenced documents are indispensable for the application 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 cu
28、p point ASTM A276, Standard Specification for Stainless Steel Bars and Shapes 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 F746-0
29、4, Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials ASTM B896, Standard Test Methods for Evaluating Connectability Characteristics of Electrical Conductor Materials ISO 27186:2010(E) 2 ISO 2010 All rights reserved3 Terms and definitions For the purposes of
30、 this document, the following terms and definitions apply. 3.1 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 tri
31、polar (3.31), integrated bipolar (3.15), and four-pole (3.8). 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 con
32、tact mechanism conductive hardware within the connector cavity 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
33、of a lead is the electrode that is farthest from the lead connector 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
34、electrodes NOTE Generally a four-pole ICD lead has two low voltage 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
35、where electrical contact with a lead connector is to occur 3.10 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
36、of the lead connector from the connector cavity ISO 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 t
37、hat has high voltage contacts NOTE A high voltage 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 inser
38、tion of a lead connector into a connector cavity 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
39、two separate lead connector contacts. 3.16 lead 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 connec
40、tor pin most proximal conductive element of 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 conn
41、ector cavity NOTE The four-pole connector has 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 impu
42、lses. Low voltage electrodes are used for transmitting 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
43、voltage (3.12). ISO 27186:2010(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 v
44、erification that the lead connector 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 cav
45、ity NOTE The pristine contact 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 ca
46、vity 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. Therefore, the most proximal electrode o
47、f a lead is the electrode closest to the lead connector pin. See also distal (3.6). 3.27 pulse generator device that delivers electrical energy to affect cardiac rhythms 3.28 sealing mechanism circumferential barriers within the connector cavity intended to maintain electrical isolation between elec
48、trically insulated parts of an assembled and implanted connector system 3.29 securing mechanism mechanism within the connector cavity intended for mechanically securing the lead connector NOTE A securing mechanism can be an active mechanism such as a set screw or it can be a passive mechanism such a
49、s a self-engaging latch. It can also serve a second function of providing electrical contact with the lead connector, as is the case with a set screw. 3.30 strain relief zone zone on the lead connector provided for making a gradual transition from a more rigid section to a more flexible section NOTE The gradual transition results in an area over which strain is distributed so that concentrated mechanical forces do not occur when the lead is flexed. ISO 27186:2010(E) ISO 2010 All rights reserved 53.31 tripolar having three poles
