YY 0989.7-2017 in English

VALID

Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems

Issued on:2017-07-17
Implemented on:2018-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $300.00
$291.00

Standard No:	YY 0989.7-2017
Document status:	VALID
Title in English:	Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems
Title in Chinese:	手术植入物有源植入式医疗器械第7部分：人工耳蜗植入系统的专用要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2017-07-17
Implemented on:	2018-01-01
ICS Classification:	11.040.40-Implants for surgery, prosthetics and orthotics
Chinese Classification:	C35-Orthopedic devices
Professional Classification:	YY-Pharmaceutics
Related Keywords:	active implantable medical devices implantable medical devices cochlear implant systems scopethis part particular requirements surgery active
Related Topics:	Implantation program implant measurement system Implantation program implantable chip implantable probe Implantable Positioning Chip implanted medical device Direct Implantable In Vivo Analysis implantable artificial kidney implanted kidney implantable mobile phone Implantable wireless charging Active Implantable Medical Devices implant shock For Active Implants implanted medical device acetone Implantable medical device products Medical implant aluminum alloy Heavy metal content in implantable medical devices implant system Medical implant device surface

本标准规定了适用于预期通过电刺激听觉通路来治疗听力障碍的有源植入式医疗器械的专用要求，本标准同样适用于器械的某些非植入部分和附件。
本标准不适用于通过非电刺激方式治疗听力障碍的器械。植入部分的电特性应通过本部分中列述的适当方法或其他方法进行验证，其他方法的准确度应能被证明是等于或优于规定的方法。
如有争议，应采用本部分规定的方法。

Scope

This part of YY 0989 specifies special requirements for the treatment of hearing impairment through active implantable medical devices. This part does not apply to devices that treat hearing impairment through non-electrical stimulation. The tests specified in this section shall use appropriate test methods to confirm compliance. This section also applies to related non-implantable parts and accessories.

More samples: GB 18306-2015 NB/T 47013.2-2015 JGJ 94-2008

Sample only — not a preview of YY 0989.7-2017

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