ISO 27186:2020
(Main)Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document 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 appropriate test methods. NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document 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 document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document 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 document does not specify all connector features. This document does 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 document can be safe and reliable and can have clinical advantages.
Dispositifs médicaux actifs implantables — Systèmes de branchement à quatre pôles pour dispositifs implantables de gestion du rythme cardiaque — Exigences de dimensions et d'essai
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INTERNATIONAL ISO
STANDARD 27186
Second edition
2020-11
Active implantable medical devices —
Four-pole connector system for
implantable cardiac rhythm
management devices — Dimensional
and test requirements
Dispositifs médicaux actifs implantables — Systèmes de branchement
à quatre pôles pour dispositifs implantables de gestion du rythme
cardiaque — Exigences de dimensions et d'essai
Reference number
ISO 27186:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO 27186:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in 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 ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 27186:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 5
4.1 General . 5
4.2 Lead connector physical requirements. 5
4.2.1 Dimensions . 5
4.2.2 Materials .10
4.2.3 Lead connector electrical connections .10
4.2.4 Lead marking .10
4.2.5 Lead package labels and literature .12
4.3 Lead connector functional requirements .12
4.3.1 Functional dimensional check . .12
4.3.2 Tensile loads .13
4.3.3 Deformation due to pin contact forces .13
4.3.4 Deformation due to ring contact forces .13
4.3.5 Seal zone requirement .14
4.3.6 Electrical isolation requirement .14
4.3.7 Dielectric strength requirement .15
4.3.8 Current-carrying requirement .15
4.3.9 Corrosion/environmental .15
4.4 Connector cavity physical requirements .15
4.4.1 Dimensions .15
4.4.2 Connector cavity electrical connections .18
4.4.3 Connector cavity/pulse generator marking .18
4.4.4 Pulse generator labels and literature .19
4.5 Connector cavity functional requirements .19
4.5.1 Insertion force .19
4.5.2 Retention force .20
4.5.3 Withdrawal force .21
4.5.4 Ring contact load .21
4.5.5 Seal zone load requirement .22
4.5.6 Electrical isolation requirement .22
4.5.7 Dielectric strength requirement .22
4.5.8 Current-carrying requirement (high-voltage connector cavity) .22
4.5.9 Contact resistance/stability .22
Annex A (normative) Electrical isolation test .23
Annex B (informative) Rational for Annex A .28
Annex C (normative) Dielectric strength test .30
Annex D (informative) Rational for Annex C .35
Annex E (normative) Current-carrying test high-voltage types .39
Annex F (informative) Rational 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
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ISO 27186:2020(E)
Annex K (informative) Rational for Annex J .58
Annex L (informative) Selection of contact materials .60
Annex M (normative) Lead connector contact material requirements.62
Annex N (informative) Rational for Annex M .66
Annex O (informative) Rationale for requirements in this document .72
Annex P (informative) Connector products .79
Bibliography .81
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ISO 27186:2020(E)
Foreword
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 technical
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
electrotechnical standardization.
The procedures used to develop this document and those intended for 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/ 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 in 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www .iso .org/ iso/ foreword .html.
This document was prepared jointly by Technical Committee ISO/TC 150, Implants for surgery,
Subcommittee SC 6, Active implants, and Technical Committee IEC/SC 62D, Electromedical equipment.
The draft was circulated for voting to the national bodies of both ISO and IEC.
This second edition cancels and replaces the first edition (ISO 27186:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— minor typographical errors have been corrected;
— the notch feature on lead connector pins has been made optional whereas previously it was required;
— the use of the notch feature for retention is no longer permitted;
— a clarification has been made to verify the functional sealing and functional contact zone
requirements in 4.4.1.2 and 4.4.1.3.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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ISO 27186:2020(E)
Introduction
The four-pole connector was created to reduce the number of individual lead connectors, to reduce
pocket bulk associated with existing bifurcated or trifurcated leads, to reduce interaction of the lead
bodies in the pocket and to reduce set screw connections.
The intent of this document is to define a four-pole connector assembly that provides interchangeability
between implantable leads and pulse generators from different manufacturers.
This document establishes two types 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-voltage 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 document 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.
vi © ISO 2020 – All rights reserved
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INTERNATIONAL STANDARD ISO 27186:2020(E)
Active 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 document 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 document is not to be used on leads intended for low-voltage
only therapy.
1 Scope
This document specifies a four-pole connector system for implantable cardiac rhythm management
(CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document
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 appropriate test methods.
NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the
responsibility of the manufacturer.
This document 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 document is not applicable to high-voltage systems with intended outputs greater than 1 000 V
and/or 50 A. This document 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 document does not specify all connector features.
This document does 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 document can be safe and reliable
and can have clinical advantages.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 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 Implant
Materials
© ISO 2020 – All rights reserved 1
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ISO 27186:2020(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
axial pin movement
axial movement of a lead connector pin (3.18) with reference to the lead connector (3.16) body as present
in some designs, particularly those with a rotating connector pin
3.2
bipolar
having two poles or electrodes
Note 1 to entry: See also tripolar (3.31), integrated bipolar (3.15), and four-pole (3.8).
3.3
connector system
assembly consisting of a lead connector (3.16) and a connector cavity (3.4) that are electrically and
mechanically joined
3.4
connector cavity
cavity within the pulse generator (3.27) which is intended to receive a lead connector (3.16)
3.5
contact mechanism
conductive hardware within the connector cavity (3.4) provided for making electrical connection to
corresponding contacts on a lead connector (3.16)
3.6
distal
farthest from a point of reference
Note 1 to entry: The point of reference for a lead is the lead connector pin (3.18). Therefore, the most distal
electrode 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 (3.18) and within the connector cavity (3.4) where the lead
connector (3.16) is mechanically secured within the connector cavity
3.8
four-pole
having four poles or electrodes
Note 1 to entry: Generally a four-pole ICD lead has two low-voltage (3.21) electrodes and two high-voltage
(3.12) 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 (3.4) where electrical contact with a lead connector (3.16) occurs
3.10
functional seal zone
zone within the connector cavity (3.4) where sealing contact with a lead connector (3.16) occurs
2 © ISO 2020 – All rights reserved
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ISO 27186:2020(E)
3.11
grip zone
area of the lead connector (3.16) which is provided for grasping during insertion and withdrawal of the
lead connector from the connector cavity (3.4)
3.12
high-voltage
electrical potential greater than 20 V and that can go up to 1 000 V
Note 1 to entry: High-voltages are generally used for defibrillating the heart.
3.13
high-voltage connector
lead connector (3.16) or connector cavity (3.4) that has high-voltage (3.12) contacts
Note 1 to entry: A high-voltage connector may also contain low-voltage (3.21) contacts. See also low-voltage only
connector (3.22).
3.14
insertion indicator zone
zone on the pin of the lead connector (3.16) allocated for manufacturers to provide a visual indicator for
use in verifying full insertion of a lead connector into a connector cavity (3.4)
3.15
integrated bipolar
two lead poles or lead electrodes (3.20) that are electrically common
Note 1 to entry: A typical integrated bipolar ICD lead has a distal (3.6) shock electrode that doubles as a proximal
(3.26) pace/sense ring electrode and is electrically attached to two separate lead connector contacts (3.17).
3.16
lead connector
part of a lead that is intended for insertion into the connector cavity (3.4) of a pulse generator (3.27)
3.17
lead connector contacts
conductive elements on the lead connector (3.16) which include the lead connector pin (3.18) and lead
connector rings (3.19)
3.18
lead connector pin
most proximal (3.26) conductive element of a lead connector (3.16) provided for making electrical
contact as well as for securing the lead connector within the connector cavity (3.4)
3.19
lead connector ring
annular conductive element on the lead connector (3.16) intended for making electrical contact within
the connector cavity (3.4)
Note 1 to entry: The four-pole (3.8) connector has three lead connector rings and a lead connector pin (3.18).
3.20
lead electrode
distal (3.6) part of a lead through which electrical impulses are transmitted to or from cardiac tissue
Note 1 to entry: High-voltage (3.12) electrodes are capable of delivering high-voltage electrical impulses. Low-
voltage (3.21) electrodes are used for transmitting and sensing low-voltage impulses and are generally not
suitable for delivering high-voltage.
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ISO 27186:2020(E)
3.21
low-voltage
electrical potential less than or equal to 20 volts
Note 1 to entry: Low-voltage is generally used for pacing and sensing the heart. See also high-voltage (3.12).
3.22
low-voltage only connector
lead connector (3.16) or connector cavity (3.4) that has only low-voltage (3.21) contacts
Note 1 to entry: See also high-voltage connector (3.13).
3.23
pin visibility zone
zone within the connector cavity (3.4) which is allocated for visual verification that the lead connector
(3.16) is fully inserted
Note 1 to entry: It corresponds to the insertion indicator zone (3.14) of the lead connector.
3.24
pristine contact zone
zone on the lead connector (3.16) which defines the minimum surface required for making electrical
contact with the mating contact in the connector cavity (3.4)
Note 1 to entry: The pristine contact zones of the lead connector align with the functional contact zones (3.9) of
the connector cavity (3.4) when the connectors are mated.
3.25
pristine seal zone
zone on the lead connector (3.16) which defines the minimum surface required for sealing with the
mating seals in the connector cavity (3.4)
Note 1 to entry: The pristine seal zones of the lead connector align with the functional seal zones (3.10) of the
connector cavity (3.4) when the connectors are mated.
3.26
proximal
nearest to a point of reference
Note 1 to entry: The point of reference for a lead is the lead connector pin (3.18). Therefore, the most proximal
electrode of 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 (3.4) intended to maintain electrical isolation
between electrically insulated parts of an assembled and implanted connector system (3.3)
3.29
securing mechanism
mechanism within the connector cavity (3.4) intended for mechanically securing the lead connector
(3.16), typically a set screw
4 © ISO 2020 – All rights reserved
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ISO 27186:2020(E)
3.30
strain relief zone
zone on the lead connector (3.16) provided for making a gradual transition from a more rigid section to
a more flexible section
Note 1 to entry: 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.
3.31
tripolar
three poles or electrodes
Note 1 to entry: See also bipolar (3.2) and four-pole (3.8).
4 Requirements
4.1 General
Not all connector features or pulse generator features are specified nor do the requirements in this
document address all aspects of functional compatibility, safety or reliability of leads and pulse
generators assembled into a system. Each manufacturer is responsible for any requirements and tests
necessary to address these as well as the biocompatibility and biostability of their material choices.
The test methods provided for the requirements are type (qualification) tests and are not intended to
be used as routine production tests. Alternate test methods may be used, including those which result
in equivalent or more stringent test conditions. However, in the event of dispute, the test methods
described in this document shall be used.
The following tests should be conducted under ambient conditions unless otherwise specified. Each
manufacturer is responsible for any preconditioning required to represent “as-shipped” configurations,
as well as for selection of appropriate sample sizes.
Leads and pulse generators marked according to Table 1 and Table 2 shall comply with all requirements
in this document.
4.2 Lead connector physical requirements
4.2.1 Dimensions
4.2.1.1 General
Lead connectors shall have the dimensions specified in Figure 1 and Figure 2 and shall meet the
requirements outlined in 4.2.1.2 to 4.2.1.11 according to each zone. See Annex O for rationale.
4.2.1.2 Total axial pin movement, M
Total axial pin movement is the difference in lead connector pin length from when the connector pin is
fully seated against datum A to when the connector pin is fully extended from datum A. Total axial pin
movement shall not be greater than 0,25 mm.
4.2.1.3 Pristine contact zones
The minimum length of each of the pristine contact zones shall be 0,90 mm + M, where M is the total
axial pin movement in millimetres.
Lead connectors shall have an electrically conductive contact surface over the entire length of each of
the pristine contact zones. Contact surfaces may extend beyond the pristine contact zones.
© ISO 2020 – All rights reserved 5
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ISO 27186:2020(E)
The surface finish in these zones shall be Ra 0,8 µm maximum. The entire surface area shall be
considered when measuring surface finish. No indentations, protrusions, gaps or steps exceeding
surface finish allowance are allowed in these zones.
4.2.1.4 Pristine seal zones
The minimum length of each pristine seal zone shall be 1,81 mm + M, where M is the total axial pin
movement in millimetres.
Lead connectors shall have a seal surface over the entire length of each of the pristine seal zones.
Seal surfaces may extend beyond the pristine seal zones. No indentation, protrusions, gaps or steps
exceeding surface finish allowance are allowed in these zones.
For surfaces of materials with hardness 75D or less, the surface finish in this zone shall be Ra 0,8 µm
maximum. The entire surface shall be considered when measuring surface finish except that uniform
linear protrusions, such as caused by mould parting lines, may be excluded from the measurement if
they do not exceed 0,025 mm in height as measured radially or 0,12 mm in width.
For surfaces in this zone made from materials with hardness above 75D, the surface finish shall be
Ra 0,4 µm maximum when the entire surface is considered, including any uniform linear protrusions.
4.2.1.5 Lead connector body
The diameter for all conductive components and surfaces within this zone shall be 3,2 mm ± 0,03 mm.
The diameter for all non-conductive components and surfaces within this zone shall be
3,2 mm ± 0,05 mm.
For all areas in this zone except pristine seal zones and pristine contact zones, the following
requirements apply.
a) Any radial steps or protrusions, such as can occur between two adjacent components or by welds,
shall not exceed 0,05 mm (in height) and shall not cause the diameter to go outside the tolerance
specified with the following exception. Uniform linear protrusions that do not exceed 0,025 mm in
height as measured radially or 0,12 mm in width are allowed only for surfaces of materials that are
at 75 Shore D or below.
b) Any gap shall not exceed 0,1 mm in width when measured to include all edge breaks at the gap edge.
There shall not be more than one gap between each pristine zone. For any gap that meets these
requirements, the area within the gap need not meet the other requirements of this subclause, for
examp
...
DRAFT INTERNATIONAL STANDARD
ISO/DIS 27186
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-08 2020-04-01
Active implantable medical devices — Four-pole connector
system for implantable cardiac rhythm management
devices - Dimensional and test requirements
Dispositifs médicaux actifs implantables — Systèmes de branchement à quatre pôles pour dispositifs
implantables de gestion du rythme cardiaque — Exigences de dimensions et d'essai
ICS: 11.040.40
Member bodies are requested to consult relevant national interests in IEC/SC
62D before casting their ballot to the e-Balloting application.
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 27186:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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ISO/DIS 27186:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in 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 ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/DIS 27186:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 5
4.1 General . 5
4.2 Lead connector physical requirements. 5
4.2.1 Dimensions . 5
4.2.2 Materials . 9
4.2.3 Lead connector electrical connections .10
4.2.4 Lead marking .10
4.2.5 Lead package labels and literature .11
4.3 Lead connector functional requirements .11
4.3.1 Functional check .11
4.3.2 Tensile loads .12
4.3.3 Deformation due to pin contact forces .13
4.3.4 Deformation due to ring contact forces .13
4.3.5 Seal zone requirement .14
4.3.6 Electrical isolation requirement .14
4.3.7 Dielectric strength requirement .15
4.3.8 Current-carrying requirement .15
4.3.9 Corrosion/environmental .15
4.4 Connector cavity physical requirements .15
4.4.1 Dimensions .15
4.4.2 Connector cavity electrical connections .18
4.4.3 Connector cavity/pulse generator marking .18
4.4.4 Pulse generator labels and literature .19
4.5 Connector cavity functional requirements .19
4.5.1 Insertion force .19
4.5.2 Retention force .20
4.5.3 Withdrawal force .21
4.5.4 Ring contact load .21
4.5.5 Seal zone load requirement .22
4.5.6 Electrical isolation requirement .22
4.5.7 Dielectric strength requirement .22
4.5.8 Current-carrying requirement (high-voltage connector cavity) .22
4.5.9 Contact resistance/stability .22
Annex A (normative) Electrical isolation test .23
Annex B (informative) Rational for Annex A .28
Annex C (normative) Dielectric strength test .30
Annex D (informative) Rational for Annex C .35
Annex E (normative) Current-carrying test high-voltage types .39
Annex F (informative) Rational 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
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ISO/DIS 27186:2020(E)
Annex K (informative) Rational for Annex J .58
Annex L (informative) Selection of contact materials .60
Annex M (normative) Lead connector contact material requirements.62
Annex N (informative) Rational for Annex M .66
Annex O (informative) Rationale for requirements in this document .72
Annex P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.) .79
Bibliography .81
iv © ISO 2020 – All rights reserved
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ISO/DIS 27186:2020(E)
Foreword
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 technical
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
electrotechnical standardization.
The procedures used to develop this document and those intended for 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/ 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 in 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 6, Active implants.
This second edition cancels and replaces the first edition (ISO 27186:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Minor typographical errors were corrected.
— The notch feature on lead connector pins was made optional whereas previously it was required.
— Use of the notch feature for retention is no longer permitted.
— Clarification was made for how to verify the functional sealing and functional contact zone
requirements in 4.4.1.2 and 4.4.1.3.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO/DIS 27186:2020(E)
Introduction
The purpose of this document is to specify a four-pole connector 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 connector 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 document establishes two types 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-voltage 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 document 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.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 27186:2020(E)
Active 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 document 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 document is not to be used on leads intended for low-voltage
only therapy.
1 Scope
This document specifies a four-pole connector system for implantable cardiac rhythm management
devices which have pacing, electrogram sensing and/or defibrillation functions. This document 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 appropriate test methods.
This document 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 document is not applicable to
high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document 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 document does not specify all connector features. It does 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 document might be safe and
reliable and might have clinical advantages.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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
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 Implant
Materials
ASTM B896, Standard Test Methods for Evaluating Connectability Characteristics of Electrical Conductor
Materials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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ISO/DIS 27186:2020(E)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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 1 to entry: See also tripolar (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
contact 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 1 to entry: 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 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 electrodes
Note 1 to entry: 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 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
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ISO/DIS 27186:2020(E)
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
3.12
high-voltage
electrical potentials greater than 20 V up to 1 000 V
Note 1 to entry: 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 1 to entry: 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 insertion of a lead connector into a connector cavity
3.15
integrated bipolar
having two lead poles or lead electrodes that are electrically common
Note 1 to entry: 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
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 connector 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
connector cavity
Note 1 to entry: 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 1 to entry: High-voltage electrodes are capable of delivering high-voltage electrical impulses. Low-voltage
electrodes are used for transmitting and sensing low-voltage impulses and are generally not suitable for
delivering high-voltage.
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ISO/DIS 27186:2020(E)
3.21
low-voltage
electrical potential less than or equal to 20 volts
Note 1 to entry: Low-voltage is generally used for pacing and sensing the heart. See also high-voltage (3.12).
3.22
low-voltage only connector
lead connector or connector cavity that has only low-voltage contacts
Note 1 to entry: 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 connector is
fully inserted
Note 1 to entry: 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 1 to entry: 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 cavity
Note 1 to entry: 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 1 to entry: The point of reference for a lead is the lead connector pin. Therefore, the most proximal electrode
of 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
electrically 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,
typically a set screw
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ISO/DIS 27186:2020(E)
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 1 to entry: 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.
3.31
tripolar
having three poles or electrodes
Note 1 to entry: See also bipolar (3.2) and four-pole (3.8).
4 Requirements
4.1 General
Not all connector features or pulse generator features are specified nor do the requirements in this
document address all aspects of functional compatibility, safety or reliability of leads and pulse
generators assembled into a system. Each manufacturer is responsible for any requirements and tests
necessary to address these as well as the biocompatibility and biostability of their material choices.
The test methods provided for the requirements are type (qualification) tests and are not intended to
be used as routine production tests. Alternate test methods may be used, including those which result
in equivalent or more stringing test conditions. However, in the event of dispute, the test methods
described in this document determine compliance.
The following tests should be conducted under ambient conditions unless otherwise specified. Each
manufacturer is responsible for any preconditioning required to represent “as-shipped” configurations,
as well as for selection of appropriate sample sizes.
Leads and pulse generators marked according to Table 1 and Table 2 shall comply with all requirements
in this document.
4.2 Lead connector physical requirements
4.2.1 Dimensions
4.2.1.1 General
Lead connectors shall have the dimensions specified in Figure 1 and Figure 2 and shall meet the
requirements outlined in 4.2.1.2 to 4.2.1.11 according to each zone.
4.2.1.2 Total axial pin movement, M
Total axial pin movement is the difference in lead connector pin length from when the connector pin is
fully seated against datum A to when the connector pin is fully extended from datum A. Total axial pin
movement shall not be greater than 0,25 mm.
4.2.1.3 Pristine contact zones
The minimum length of each of the pristine contact zones shall be 0,90 mm + M, where M is the total
axial pin movement in millimetres.
Lead connectors shall have an electrically conductive contact surface over the entire length of each of
the pristine contact zones. Contact surfaces may extend beyond the pristine contact zones.
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ISO/DIS 27186:2020(E)
The surface finish in these zones shall be Ra 0,8 µm maximum. The entire surface area shall be
considered when measuring surface finish. No indentations, protrusions, gaps or steps exceeding
surface finish allowance are allowed in these zones.
4.2.1.4 Pristine seal zones
The minimum length of each pristine seal zone shall be 1,81 mm + M, where M is the total axial pin
movement in millimetres.
Lead connectors shall have a seal surface over the entire length of each of the pristine seal zones.
Seal surfaces may extend beyond the pristine seal zones. No indentation, protrusions, gaps or steps
exceeding surface finish allowance are allowed in these zones.
For surfaces of materials with hardness 75D or less, the surface finish in this zone shall be Ra 0,8 µm
maximum. The entire surface shall be considered when measuring surface finish except that uniform
linear protrusions, such as caused by mould parting lines, may be excluded from the measurement if
they do not exceed 0,025 mm in height as measured radially or 0,12 mm in width.
For surfaces in this zone made from materials with hardness above 75D, the surface finish shall be Ra
0,4 µm maximum when the entire surface is considered, including any uniform linear protrusions.
4.2.1.5 Lead connector body
The diameter for all conductive components and surfaces within this zone shall be 3,2 mm ± 0,03 mm.
The diameter for all non-conductive components and surfaces within this zone shall be
3,2 mm ± 0,05 mm.
For all areas in this zone except pristine seal zones and pristine contact zones, the following
requirements apply.
a) Any radial steps or protrusions, such as can occur between two a
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