관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
구판
판매
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps
| 분야 | ISO/TC 150/SC 6 : Active implants |
|---|---|
| 적용범위 | ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices. The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 42 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 14708-4:2022 | Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems | 2022-02-28 | 표준 |
| 2 | ISO 14708-4:2008 | Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps | 2008-11-05 | 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
ISO/TS 10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device 상세보기
BS EN 45502-1:2015 - Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer. 상세보기
BS EN 45502-2-3:2010 - Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems. 상세보기
BS EN 61000-4-3:2006+A2:2010 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Radiated, radio-frequency, electromagnetic field immunity test. 상세보기
BS EN 61000-6-1:2007 - Electromagnetic compatibility (EMC). Generic standards. Immunity for residential, commercial and light-industrial environments. 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기
KS표준
핸드북
