This standard specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices with pacing, electrogram sensing, or defibrillation functions. This standard contains requirements for the connector portion of an implantable lead as well as the mating connector cavity connected to an implantable pulse generator. Basic dimensions and performance requirements are specified, along with appropriate test methods.
This standard does not apply to high voltage systems with intended outputs greater than 1000 V or 50 A. This standard does not apply to sensors that do not have conventional pacing, electrogram sensing or capability, or systems containing unique electrodes.
This standard does not specify all connector specifications. This standard does not address all aspects of the functional compatibility, safety, or reliability of leads and pulse generators installed in a system.
The safety, reliability, biocompatibility, biostability and function of any part are the responsibility of the manufacturer.
EUROLAB assists manufacturers with ISO 27186 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
