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Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
| 분야 | ISO/TC 150/SC 6 : Active implants |
|---|---|
| 적용범위 | This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document 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. NOTE This document is not intended to apply to non-implantable infusion systems. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 58 |
| Edition | 2 |
| 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 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/TS 10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device 상세보기
ASTM F2038-18 - Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials 상세보기
IEC 62304:2006 - Medical device software — Software life cycle processes 상세보기
ISO 10993-3:2014 - Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 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
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