ISO 27186:2026

Description

This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have electrogram sensing and pacing functions with or without defibrillation capability. This document includes requirements for the connector portion of an implantable lead and for the mating connector cavity attached to an implantable pulse generator. Key dimensions and performance requirements are specified together with appropriate test methods.

This document establishes two types of connector assembly with their configurations, which are not intended to be interchangeable:

• a high-voltage connector: a connector that can have either
• two low-voltage contacts combined with one or two high-voltage contacts, or
• only two high-voltage contacts;
• a “low-voltage only connector”: a connector that has either three or four low-voltage contacts.

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.

This document does not replace or provide alternatives for unipolar or bipolar connector International Standards that currently exist (such as ISO 11318[2] and ISO 5841-3[1]).

This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V or systems with an electric flow greater than 50 A.

This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing electrogram sensing or defibrillation functions.

This document does not specify all connector features and it does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system.

This document does not include requirements for accessories or adaptors used with four-pole connectors. Refer to Annex P for more information on connector-related products.

NOTE 1        The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer.

NOTE 2        Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.