Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
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1 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. This International Standard 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 International Standard might be safe and reliable, and might have clinical advantages.
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