ISO - DIS 27186
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
|Publication Date:||8 January 2020|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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.