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Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems
| 분야 | ISO/TC 150/SC 6 : Active implants |
|---|---|
| 적용범위 | ISO 14708-7:2013 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. The tests that are specified in ISO 14708-7:2013 are type tests and are to be carried out on samples of a device to show compliance. ISO 14708-7:2013 is also applicable to non-implantable parts and accessories of the devices. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 54 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 14708-7:2019 | Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems | 2019-12-20 | 표준 |
| 2 | ISO 14708-7:2013 | Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems | 2013-01-08 | 구판 |
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 상세보기
ISO 14708-3:2017 - Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators 상세보기
ISO 14708-2:2019 - Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers 상세보기
ISO 14708-6:2019 - Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) 상세보기
ISO 14708-7:2019 - Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems 상세보기
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices 상세보기
IEC 60601-1-11:2015 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 상세보기
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IEC 62304:2006+AMD1:2015 CSV - Medical device software - Software life cycle processes 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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