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Content DescriptionThis standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combination devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design issues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelatedmedical treatments, and normal use.
The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 8,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals. AAMI helps members:
Stay on top of new technology and policy developments
Add value in healthcare organizations
Improve professional skills
Enhance patient care
AAMI provides a unique and critical forum for a variety of professionals including clinical and biomedical engineers and technicians, physicians, nurses, hospital administrators, educators, scientists, manufacturers, distributors, government regulators, and others with an interest in healthcare technology. AAMI fulfills its mission through:
Courses, conferences, and continuing education, including certification programs.
Collaborative initiatives, including summits with the FDA
A rich array of resources, including peer-reviewed journals, technical documents, books, videos, podcasts, and other products.
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