YY 0989.7-2017: Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems

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Scope

This Part of YY 0989 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.
The tests that are specified in this Part are type tests and are to be carried out on
samples of a device to show compliance.
This Part 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 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 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, but there is a need to specify some requirements of non-implantable parts and
accessories if they could affect the safety or performance of the implantable part.

Basic Data

Standard ID	YY 0989.7-2017 (YY0989.7-2017)
Description (Translated English)	Implants for surgery -- Active implantable medical devices -- Part 7: Particular requirements for cochlear implant systems
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	38,370
Date of Issue	2017-07-17
Date of Implementation	2018-01-01
Issuing agency(ies)	State Food and Drug Administration