ISO 27186 First edition 2010-03-15

Standard Organization:

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 Date2013-01-25
Recognition List030
Recognition Number3-89
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

Rationale:

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Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions, Issued November 2000.


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