ISO 27186:2010

Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

ISO 27186:2010 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 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.

Dispositifs médicaux actifs implantables — Systèmes de branchement à quatre pôles pour gérer le rhythme cardiaque — Dimensions et exigences d'essai

General Information

• Status: Withdrawn
• Publication Date: 17-Mar-2010
• Withdrawal Date: 17-Mar-2010
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 6 - Active implants
• Drafting Committee: ISO/TC 150/SC 6/JWG 1 - Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 30-Nov-2020
• Completion Date: 13-Dec-2025

Relations

• Revised: ISO 27186:2020 - Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
• Effective Date: 24-Dec-2016

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 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 médicaux actifs implantables — Systèmes de branchement à
quatre pôles pour gérer le rhythme cardiaque — Dimensions et
exigences d'essai
Reference number
©
ISO 2010
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©  ISO 2010
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ii © ISO 2010 – All rights reserved

Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
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 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 K (informative) Rationale for Annex J.58
Annex L (informative) Selection of contact materials .60
Annex M (normative) Lead connector contact material requirements.62
Annex N (informative) Rationale for Annex M.66
Annex O (informative) Rationale for requirements in this International Standard.72
Annex P (informative) Connector products (e.g. adaptors, extenders, patient cables, etc.) .79
Bibliography.81

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.
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 to 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 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.
iv © ISO 2010 – All rights reserved

Introduction
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 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 International Standard 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 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.
INTERNATIONAL STANDARD ISO 27186:2010(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 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 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 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 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 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 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 International Standard might be safe and
reliable, and might have clinical advantages.
2 Normative 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 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.
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 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 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 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
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
2 © ISO 2010 – All rights reserved

3.12
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 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 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 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 impulses. 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 voltage (3.12).
3.22
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 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 cavity
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 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. 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
NOTE A securing mechanism can be an active mechanism such as a set screw or it can be a passive mechanism
such as 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.
4 © ISO 2010 – All rights reserved

3.31
tripolar
having three poles or electrodes
NOTE 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 4.2 to 4.5
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. Equivalent test methods may be
used. However, in the event of a dispute, the test methods described in 4.2 to 4.5 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 International Standard.
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.
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.
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 durometers of nominally 75 Shore D, 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 durometers harder than 75 Shore D nominal, 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 nominally
75 Shore D.
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
example diameter and radial step requirements.
c) Any indentations, such as holes or weld depressions, shall not exceed 0,5 mm in diameter and/or 0,5 mm
in depth.
d) Surface finish shall be Ra 1,6 µm maximum. Surface finish measurements need not include any surface
features that meet the above requirements.
4.2.1.6 Strain relief zone
The diameter in this zone shall be 4,1 mm maximum and 3,8 mm minimum.
4.2.1.7 Grip zone
The diameter in this zone shall be 4,1 mm maximum.
4.2.1.8 Chamfer zone
The length of the chamfer in this zone shall be 0,35 mm minimally and 0,7 mm − M maximally, where M is the
total axial pin movement in millimetres.
4.2.1.9 Transition zone
The transition from the ∅3,2 mm to the ∅4,1 mm diameter shall occur within the envelope between datum B
intersecting the 17,7 mm diameter and the 4,1 mm diameter and a line parallel to datum B intersecting the
18,70 mm maximum dimension.
NOTE The 60° dimension defines datum B, and transition geometry need not match this angle.
6 © ISO 2010 – All rights reserved

The diameter in this zone shall not exceed 4,1 mm.
4.2.1.10 Insertion indicator zone
This zone is provided for an optional insertion indicator. If an insertion indicator is present it shall meet the
following requirements.
a) The indicator shall not extend beyond the zone.
b) The proximal edge shall meet the 5,10 mm ± 0,10 mm dimension.
+0,03
c) The diameter shall fall within the nominal diameter specified and the tolerance of mm.
−0,10
d) Any gaps shall not exceed 0,10 mm in width. For any gap that meets this requirement, the area within the
gap need not meet the other requirements of this section, for example diameter and radial step
requirements.
e) Any radial steps shall not exceed 0,05 mm.
4.2.1.11 Pin pristine contact zone
Lead connectors shall have an electrical contact surface over the entire length of this zone.
The surface finish in this zone shall be Ra 0,8 µm maximum.
Dimensions in millimetres
Key
1 pristine contact zones 5 grip zone
2 pristine seal zones 6 chamfer zone
3 lead connector body 7 transition zone
4 strain relief zone 8 total axial pin movement, M
NOTE The diameter dimensions of the soft sections, in zone 4, zone 5 and zone 7, 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.
Figure 1 — Four-pole lead connector body
Dimensions in millimetres
a)  High voltage lead connector pin

b)  Low voltage only lead connector pin
Key
1 pin fixation zone
2 pin pristine contact zone
3 insertion indicator zone
a
Dimension applies when amount of pin axial movement has been minimized such as by axially seating the connector
pin against datum A.
Figure 2 — Four-pole lead connector high voltage and low voltage only pin details
8 © ISO 2010 – All rights reserved

4.2.2 Materials
4.2.2.1 Contact materials
Lead connector contact materials shall meet the requirements of Annex M.
Based on observations made during the development of this International Standard, it is recommended that
manufacturers consider selecting 35Cobalt-35Nickel-20Chromium-10Molybdenum alloy specified in
ASTM F562 as a material for lead connector contacts. This material performed acceptably when evaluated by
multiple manufacturers and was more consistent than several other materials tried. Contact material was
identified as critical to connector performance and therefore verification to the requirements in this
International Standard should be made when using this or any other material.
4.2.2.2 Seal surface material
Lead connector seal zone materials are not specified; however, recommendations are provided in Annex H.
4.2.3 Lead connector electrical connections
4.2.3.1 According to the appropriate configuration, each lead connector contact shall be in electrical
continuity with the specific and distinct lead electrode described in Table 1 when the following applies:
⎯ “LOW voltage” refers to stimulating electrodes having pacing and electrogram sensing function;
⎯ “HIGH voltage” refers to stimulating electrodes having high voltage defibrillation capability;
⎯ “OPEN” refers to lead connector contacts that are not in electrical continuity with any lead electrode.
4.2.3.2 The lead connector pin of low voltage only lead connectors shall conform to Figure 2 b).
4.2.3.3 The lead connector pin of high voltage lead connectors including integrated bipolar connectors
shall conform to Figure 2 a).
NOTE Ring 2 and ring 3 contacts of high voltage lead connectors should not be in direct electrical continuity with lead
electrodes that are not intended for high voltage.
4.2.4 Lead marking
4.2.4.1 Marking symbol
Lead connectors shall be marked with the appropriate symbol according to Table 1 and sized appropriately for
the component being marked.
4.2.4.2 Marking location
Marking shall be located in the marking zone (see Figure 3).
4.2.4.3 Marking orientation
Marking shall read left to right when the lead connector is oriented with the connector pin to the left.
NOTE It is the responsibility of the manufacturer to ensure marking on lead connectors is permanent and legible
under intended use conditions.
Dimensions in millimetres
Key
1 marking zone
2 lead connector pin
3 lead connector ring 1
4 lead connector ring 2
5 lead connector ring 3
Figure 3 — Identification of lead connector contacts
Table 1 — Lead marking symbols and electrical connections within the lead — Permitted
configurations
Configuration
and marking Connector pin Ring 1 Ring 2 Ring 3
symbol
Most distal LOW 2nd most distal LOW 3rd most distal LOW Most proximal LOW
IS4-LLLL
voltage electrode voltage electrode voltage electrode voltage electrode
Low
Most distal LOW 2nd most distal LOW 3rd most distal LOW
voltage
IS4-LLLO OPEN
voltage electrode voltage electrode voltage electrode
only
Most distal LOW 2nd most distal LOW Most proximal LOW
IS4-LOLL OPEN
voltage electrode voltage electrode voltage electrode
Most distal LOW 2nd most distal LOW Most distal HIGH Most proximal HIGH
DF4-LLHH
voltage electrode voltage electrode voltage electrode voltage electrode
High
Most distal LOW 2nd most distal LOW Most distal HIGH
DF4-LLHO OPEN
voltage voltage electrode voltage electrode voltage electrode
Most distal HIGH Most proximal HIGH
DF4-OOHH OPEN OPEN
voltage electrode voltage electrode
a
Most distal LOW Most distal HIGH Most distal HIGH Most proximal HIGH
DF4-LLHH
voltage electrode voltage electrode voltage electrode voltage electrode
Integrated
bipolar
a
Most distal LOW Most distal HIGH Most distal HIGH
DF4-LLHO OPEN
voltage electrode voltage electrode voltage electrode

a
For integrated bipolar leads the most distal HIGH voltage electrode may also be used for low voltage pacing and sensing function.
4.2.5 Lead package labels and literature
Package labels and product literature are the responsibility of the lead manufacturer; however, the appropriate
marking symbols shown in Table 1 should be used at all times when referring to lead connectors conforming
to this International Standard.
NOTE The four-pole lead connectors specified in this International Standard might not be compatible with the wide
variety of existing analyser cables that are currently used with other connectors (such as IS-1 and DF-1). Specifically, the
terminals of some analyser cables can result in bridging and shorting of the more closely-spaced lead connector contacts
of the four-pole connector. Bridging and shorting during an implant procedure can result in erroneous measurements of
10 © ISO 2010 – All rights reserved

performance characteristics (e.g. R waves, P waves, impedances, pacing thresholds) or a temporary inability to provide
pacing therapy. Manufacturers are individually responsible for providing appropriate warnings, education or other means
of mitigating the risk of bridging and shorting as can occur due to use of analyser cable terminals with their respective lead
connectors. See also Clause P.3.
4.3 Lead connector functional requirements
4.3.1 Functional check
4.3.1.1 Test method
Insert the lead connector into the lead connector go gauge conforming to Figure 4. Perform this test both with
the lead connector in an initial state and after a 10 d minimum soak in saline (nominally 9 g/l at 37 °C ± 5 °C).
Dimensions in millimetres
a
The 3,28 mm maximum diameter exceeds the largest permissible lead diameter by 0,03 mm to accommodate axis
curvature of the lead connector or localized offsets that might be present between lead connector components.
b
Radius or chamfer u 0,20 mm.
c
Edge break u 0,1 mm.
d
Material: metal.
Figure 4 — Lead connector go gauge
4.3.1.2 Requirement
Both initially and after soaking, the force to fully insert the lead connector into the lead connector go gauge
shall be less than 4,5 N. The lead connector is considered fully inserted into the gauge when the connector
pin is visible outside the 1,43 mm diameter. The lead connector need not be bottomed out in the gauge in
order to be considered fully inserted.
4.3.2 Tensile loads
4.3.2.1 Test method
Soak the lead connector in saline (nominally 9 g/l at 37 °C ± 5 °C) for 10 d minimum prior to testing. After
soaking and while in a wetted state, fasten the lead connector at the lead connector pin and apply a tensile
load of 14 N minimum at the grip zone. Maintain the load for at least 10 s. Repeat tensile loading a minimum
of five cycles.
4.3.2.2 Requirement
After tensile loading the lead shall meet the linear dimensions in Figures 1 and 2 measured from datum A and
the requirements of 4.2.1.2, 4.3.6, 4.3.7 and 4.3.8.
4.3.3 Deformation due to pin contact forces
4.3.3.1 Test method
Insert the lead connector into a test cavity that conforms to the bore dimensions of Figure 7 a) for high voltage
and Figure 7 b) for low voltage only and which has M2 screw threads located within the functional pin contact
zone. Use an M2 titanium grade 5 as described in ASTM B348, 860 MPa minimum tensile strength, set screw
with cup point that complies with ISO 7436.
Tighten the screw to a torque of 0,15 N⋅m ± 0,01 N⋅m. Maintain the load for 10 s minimum and then release
the set screw.
4.3.3.2 Requirement
The force to withdraw the lead connector from and re-insert it into the test cavity shall not exceed 4,5 N.
After removal, the lead connector shall meet the contact zone diameter requirements in Figure 2.
NOTE 1 For lead connector designs utilizing a through-hole for stylets, it is recommended that the manufacturer verify
that the through-hole is still functional following application of the set screw load.
NOTE 2 It is recognised that at the time of this International Standard most manufactured devices utilize 2-56 hexagon
head set screws for lead connector retention. Although they are similar in size, the equivalency between the two types of
set screw has not been established. Therefore an M2 set screw is specified herein for use in a dispute.
NOTE 3 Lead manufacturers are encouraged to evaluate the durability of their lead connector insertion indicator zone
when exposed to the forces associated with handling and implanting conditions, including use with patient cable alligator
clips, passive retention systems, set screws and other types of tool that might be used during an implant procedure.
Manufacturers should confirm that the insertion indicator does not become functionally degraded or dislodged from the
lead connector pin after exposure to handling and implant conditions.
4.3.4 Deformation due to ring contact forces
4.3.4.1 Test method
Use two aligned metal blade indenters that conform to Figure 5 to apply a compressive load to the outer
diameter of each ring in the pristine contact zone (see Figure 1). Apply a minimum load of 9 N and maintain
the load for a minimum of 10 s.
12 © ISO 2010 – All rights reserved

Dimensions in millimetres
a
Material: metal.
Figure 5 — Ring contact force test fixture
4.3.4.2 Requirement
After application and release of the load, the lead connector shall meet the requirements of 4.2.1.5 with the
exception of the surface finish requirement, the functional check of 4.3.1 and the electrical requirements of
4.3.6, 4.3.7 and 4.3.8.
4.3.5 Seal zone requirement
There is no functional requirement for seal zones. See Annex H and Annex I for design recommendations.
4.3.6 Electrical isolation requirement
The lead connector shall provide electrical isolation between each of the lead connector contacts and between
the contacts and the surrounding fluid. Compliance shall be determined as described in Annex A.
4.3.7 Dielectric strength requirement
The lead connector shall provide high voltage electrical isolation between each of the lead connector contacts
and between the contacts and the surrounding fluid. This requirement applies only to high voltage lead
connectors. Compliance shall be determined as described in Annex C.
4.3.8 Current-carrying requirement
The high voltage lead connectors shall be capable of carrying defibrillation current. Compliance shall be
determined as described in Annex E.
4.3.9 Corrosion/environmental
Compliance shall be determined as described in Annex M.
4.4 Connector cavity physical requirements
4.4.1 Dimensions
4.4.1.1 General
The connector cavity shall have the dimensions specified in Figure 6 and Figure 7 and shall meet the following
requirements according to each zone.
4.4.1.2 Functional contact zones
The electrically active contact surfaces for mating with the lead connector shall be located within the functional
contact zones (see Figure 6) and functional pin contact zone (see Figure 7). Contact hardware may extend
beyond these zones. This requirement does not apply for contacts that are not active.
4.4.1.3 Functional seal zones
Connector cavities shall provide for functional sealing within the functional seal zones (see Figure 6). Seal
hardware may extend beyond these zones.
4.4.1.4 Material
The structural support of the connector cavity shall be constructed of a material with a minimum hardness of
70 Shore D.
14 © ISO 2010 – All rights reserved

Dimensions in millimetres
Key
1 functional contact zones
2 functional seal zones
3 stabilization zone
a
The surface of the bore entrance need not be perpendicular to the bore axis as long as the entire circumference of the
bore entrance is located within the 22,6 mm minimum and 24,6 mm maximum specified.
b
Radius or chamfer, 0,33 mm ± 0,13 mm.
Figure 6 — Four-pole connector cavity
Dimensions in millimetres
a)  High voltage pin cavity
b)  Low voltage only pin cavity
Key
1 functional contact zone 2 pin visibility zone
a
Securing mechanisms can have features that are smaller than the 1,48 mm diameter as necessary to secure the lead
connector.
Figure 7 — Four-pole connector cavity tip detail
16 © ISO 2010 – All rights reserved

4.4.2 Connector cavity electrical connections
4.4.2.1 According to the appropriate configuration, each connector cavity contact shall be in electrical
continuity with the specific device outputs described in Table 2 when the following applies:
⎯ “LOW” are device outputs u 20 V;
⎯ “HIGH” are device outputs between 20 V and 1 000 V peak and < 50 A;
⎯ “OPEN” refers to connector cavity contacts that are not in electrical continuity with any device output.
4.4.2.2 Low voltage only version connector cavities shall conform to Figure 7 b).
4.4.2.3 High voltage version connector cavities shall conform to Figure 7 a).
NOTE Connector cavity contacts designated as low voltage are not designed to deliver high voltage output.
4.4.3 Connector cavity/pulse generator marking
Pulse generators with connector cavities conforming to this International Standard shall be marked with the
appropriate symbols in accordance with Table 2 and sized appropriately for the component being marked.
NOTE It is the responsibility of the manufacturer to ensure marking on pulse generators is permanent and legible
under intended use conditions.

Key
1 pin contact
2 ring 1 contact
3 ring 2 contact
4 ring 3 contact
Figure 8 — Identification of contacts in the connector cavity
Table 2 — Pulse generator marking symbols and electrical connections to device outputs —
Permitted configurations
Connector cavity contacts
Configuration and
marking symbol
Pin contact Ring 1 contact Ring 2 contact Ring 3 contact
IS4-LLLL LOW LOW LOW LOW
Low voltage
IS4-LLLO LOW LOW LOW OPEN
only
IS4-LOLL LOW OPEN LOW LOW
DF4-LLHH LOW LOW HIGH HIGH
High voltage DF4-LLHO LOW LOW HIGH OPEN
DF4-OOHH OPEN OPEN HIGH HIGH
4.4.4 Pulse generator labels and literature
The appropriate marking symbols shown in Table 2 should be used at all times when referring to connectors
conforming to this International Standard.
NOTE Package labels and product literature are the responsibility of the pulse generator manufacturer.
4.5 Connector cavity functional requirements
4.5.1 Insertion force
4.5.1.1 Test method
Fully insert the metal gauge pin specified in Figure 9 into the device connector cavity while measuring the
maximum force required. Remove the insertion force while observing for any displacement of the gauge pin
for 15 s minimum.
This test shall be performed in accordance with the manufacturer's recommended implant procedure. This test
shall be performed dry.
4.5.1.2 Requirement
The maximum force required to fully insert the gauge pin into the device connector cavity shall not exceed
16 N.
The gauge pin shall not become displaced more than 0,5 mm after the insertion force is removed when
verified after 15 s minimum.
The connector cavity shall meet the dimensional requirements of Figure 6 and the requirements of 4.5.6, 4.5.7
and 4.5.8.
18 © ISO 2010 – All rights reserved

Dimensions in millimetres
a
Material: metal (entire pin).
Figure 9 — Maximum connector cavity gauge pin
4.5.2 Retention force
4.5.2.1 Test method
Fully insert the minimum retention gauge pin conforming to Figure 10 into the connector cavity and engage
the securing mechanism, as applicable, per manufacturer instructions. Apply an axial tensile load of 10 N for
10 s minimum while observing for displacement of the gauge pin.
4.5.2.2 Requirement
The gauge pin shall not become displaced more than 0,5 mm while under the 10 N load.
Dimensions in millimetres
a
Material: metal (entire pin).
Figure 10 — Minimum retention gauge pin
4.5.3 Withdrawal force
4.5.3.1 Test method
Insert the gauge pin conforming to Figure 9 fully into the connector cavity. Verify that any active retention
mechanisms are disengaged. Fully withdraw the gauge pin whilst measuring the maximum force required.
Perform this test under initial (dry) conditions.
4.5.3.2 Requirement
The maximum force required to fully withdraw the gauge pin shall not exceed 14 N.
4.5.4 Ring contact load
4.5.4.1 Applicability
This requirement applies only to contact mechanisms for lead connector rings that require activation after the
lead connector is inserted, such as set screws.
4.5.4.2 Test method
Determine the maximum contact load of the fully activated contact mechanism over a 3,23 mm diameter test
pin.
4.5.4.3 Requirement
Contact load shall not exceed the maximum allowed by 4.3.4.
20 © ISO 2010 – All rights reserved

4.5.5 Seal zone requirement
There is no functional requirement for seal zones. See Annex I for design recommendations.
4.5.6 Electrical isolation requirement
The connector cavity shall provide electrical isolation between each of the connector cavity contacts and
between the contacts and the surrounding fluid. Compliance shall be determined as described in Annex A.
4.5.7 Dielectric strength requirement
The connector cavity shall provide high voltage electrical isolation between each of the connector cavity
contacts and between the contacts and the surrounding fluid. This requirement applies to high voltage
connector cavities. Compliance shall be determined as described in Annex C.
4.5.8 Current-carrying requirement (high voltage connector cavity)
The high voltage type connector cavity shall be capable of carrying defibrillation current. Compliance shall be
determined as described in Annex E.
4.5.9 Contact resistance/stability
There is no requirement for contact resistance/stability since it is dependent on each specific device system's
performance.
NOTE It is recommended that each manufacturer evaluate the contact resistance/stability as part of their device
reliability and safety testing. See Annex J for a description of one potential test method believed to be practical for
measuring the relative performance of various spring contact designs.
Annex A
(normative)
Electrical isolation test
A.1 General
A.1.1 Purpose
This annex desc
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