ISO 27186:2020

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 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

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
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
iv © ISO 2020 – All rights reserved

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.
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
...