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ANSI/AAMI/ISO 14708-1:2014
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
Specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in this document are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This document is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources. This document is also applicable to some non-implantable parts and accessories of the active implantable medical devicesthe patient
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Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]