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ISO 27186

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

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Organization: ISO
Publication Date: 1 November 2020
Status: active
Page Count: 88
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) 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.

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

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.

This document 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 can be safe and reliable and can have clinical advantages.

Document History

ISO 27186
November 1, 2020
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document...
March 15, 2010
Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
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...

References

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