Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements (ISO 27186:2010, IDT)
This Malaysian Standard specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This 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 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 standard is not applicable to high voltage systems with intended outputs greater than 1 000 V and/or 50 A. This 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 standard does not specify all connector features. It does not addre
Published
• (none) / (none) / (none)
PDF
03/05/2019
90
NSC 18 - Medical Devices and Facilities for Healthcare
