DS/ISO 27186:2010

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*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 1000 volts and/or 50 amps. 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 1 High voltage lead connectors are intended to be used with high voltage connector cavities of the same*configuration, and low voltage only lead connectors are intended to be used with low voltage only connector cavities of the*same configuration. Any application or use other than these is outside the scope of this International Standard.*NOTE 2 Lead and pulse generator connector systems not conforming to this International Standard may be safe and*reliable, and may have clinical advantages.*