YY 0989.7-2017 Active
YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems
Abstract
This part of YY 0989 specifies the special requirements for active implantable medical devices intended to treat hearing disorders by electrical stimulation of the auditory pathway. This part does not apply to devices that treat hearing disorders by non-electrical stimulation methods.
The tests specified in this part are type tests, and compliance is confirmed through the testing of samples.
This part also applies to certain non-implantable parts and accessories of the device (see note).
The electrical characteristics of the implantable parts shall be verified by appropriate methods listed in this part or other methods, the accuracy of which shall be proven to be equal to or better than the specified methods. In case of disputes, the methods specified in this part shall be adopted.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY 0989.7-2017 |
| CCS | Orthopaedic surgery, orthopaedic instruments |
| ICS | Surgical implants, prostheses, and orthoses |
| Implement Date | 2018-01-01 |