Kirurgiska implantat, proteser och ortoser

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 4 jun 2018
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This part of ISO 14708 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this part of ISO 14708.

The tests that are specified in this part of ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.

This part of ISO 14708 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE).

The electrical characteristics of the IMPLANTABLE PART are determined by either the appropriate method detailed in this part of ISO 14708 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this part of ISO 14708 applies.

NOTE A device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, this standard specifies those requirements of NON-IMPLANTABLE PARTS and accessories which could affect the safety or performance of the implantable part.