What is ISO 27186 about?
ISO 27186 discusses the four-pole connector system for implantable cardiac rhythm management devices for active implantable medical devices. ISO 27186 outlines a four-pole connector system for implantable cardiac rhythm management (CRM) devices that have pacing, electrogram sensing, and/or defibrillation functions.
ISO 27186 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 1: The safety, reliability, biocompatibility, biostability, and function of any part are the responsibility of the manufacturer.
Note 2: It 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).
Note 3: It does not apply to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document does not apply to systems that include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing, and/or defibrillation functions.
Note 4: It does not specify all connector features and does not address all aspects of functional compatibility, safety, or reliability of leads and pulse generators assembled into a system.
Note 5: Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
Who is ISO 27186 for?
ISO 27186 on the four-pole connector system for implantable cardiac rhythm management devices is useful for:
- Manufactures of implantable medical devices
- Test centres for medical devices
- Medical implant laboratories
- Regulatory authorities
Why should you use ISO 27186?
The four-pole connector was created to reduce the number of individual lead connectors, pocket bulk associated with existing bifurcated or trifurcated leads, the interaction of the lead bodies in the pocket, and set screw connections.
ISO 27186 guideline helps you with “lead connector physical and functional requirements” and “connector cavity physical and functional requirements” for a four-pole connector system for implantable cardiac rhythm management devices. ISO 27186 also establishes two types of connector assembly: a “high-voltage connector” and a “low voltage only connector”, each of them has several configurations. This helps in interchangeability between implantable leads and pulse generators from different devices and prevents the low voltage contacts of the lead connectors from contacting the high-voltage contacts of high-voltage connector cavities.
What’s changed since the last update?
BS ISO 27186:2020 supersedes ISO 27186:2020, which has been withdrawn. BS ISO 27186:2020 has some technical changes with respect to ISO 27186:2020. These include:
- 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.
