For those of you in the medical device field, you may be interested in the new ISO 14708-7 1st Edition, “Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear implant systems,” available now from Document Center Inc. in either paper or pdf format. It specifically addresses the particular requirements for devices used to treat hearing impairment via electrical stimulation.
The challenge of cochlear implant systems (or auditory brainstem implant systems) is the fact that the device is usually composed of both implantable and non-implantable parts. For example, the power source may be part of the implantable component or not. Then too, since the system is designed to restore hearing by the use of electrical stimulation of the auditory pathway, externally processed information may be used to adjust the parameters of the device via a non-implantable accessory.
The ISO 14708 series is one of our best-selling medical device sets, comprised of the following standards:
- ISO 14708-1:2000, Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
- ISO 14708-2:2012, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
- ISO 14708-3:2008, Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
- ISO 14708-4: 2008, Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps
- ISO 14708-5:2010, Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
- ISO 14708-6:2010, Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
- ISO 14708-7:2013, Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
All ISO standards can be purchased at our webstore, www.document-center.com. Please be aware that certain territorial restrictions do apply. You can also get in touch with us via phone (650-591-7600), fax (650-591-7617), and email (info@document-center.com). We’re happy to assist you with any and all standards questions and requirements you may have.
