| ISO 27186 First edition 2010-03-15 Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements |
| Recognition Date | 2013-01-25 |
| Recognition List | 030 |
| Recognition Number | 3-89 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
| FDA Tech | Mark Fellman FDA/OMPT/CDRH/ODE/DCD/CEDB/ 301-796-6357 mark.fellman@fda.hhs.gov |
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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.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | Class 3 | OJX |
| Unclassified | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Class 3 | NVN |
| Unclassified | Implantable Cardioverter Defibrillator (Non-Crt) | Class 3 | LWS |
| Unclassified | Implantable Pulse Generator, Pacemaker (Non-Crt) | Class 3 | LWP |
| Unclassified | Permanent Defibrillator Electrodes | Class 3 | NVY |
| Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions, Issued November 2000. |