사업자등록증
해외표준
FAQ
장바구니
고객센터
해외표준 상세정보
관심표준 등록 : 표준업데이트 시 알림서비스
제공형태 더보기-
표준
판매
ISO 14708-7:2019
Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems- 발행일 : 2019-12-20
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 150/SC 6 : Active implants |
|---|---|
| 적용범위 | This document 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 document. The tests that are specified in this document are type tests and are to be carried out on samples of a device to show compliance. This document 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 document 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 document 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 document specifies those requirements of non-implantable parts and accessories which could affect the safety or performance of the implantable part. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 68 |
| Edition | 2 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 14708-7:2019상세보기 | Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems | 2019-12-20 | 표준 |
| 2 | ISO 14708-7:2013상세보기 | Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear implant systems | 2013-01-08 | 구판 |
관련상품
- 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
- ISO 14708-3:2017 - Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
- 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)
- ISO 14708-2:2019 - Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
- ISO 14708-5:2020 - Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
다른 사람이 함께 구입한 상품
- ISO 14708-2:2019 - Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
- 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)
- ISO 14708-5:2020 - Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
- ISO 14708-4:2022 - Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
- ISO/TS 22077-5:2021 - Health informatics — Medical waveform format — Part 5: Neurophysiological signals
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
제공형태 닫기
PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)보안PDF :
직접 파일 다운로드 및 인쇄(마이페이지 확인)* 단, 파일이동 및 복사 불가, 1회 다운로드 및 인쇄가능PRINT :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)BOOK :
인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)ZIP :
압축파일형태로 제공 (PDF, HTML, TXT, XLS 등으로 구성), 직접 파일 다운로드(마이페이지 확인)CD/DVD :
직접 파일 다운로드 및 인쇄(마이페이지 확인)DB :
별도 정보 제공HARDCOPY :
해외 배송 상품, 최대 3주 소요바인더 :
바인더 우편발송, 2~3일 소요온라인구독 :
WEB 접속 후 실시간 열람, 출력(1년간)