관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
표준
판매
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
| 분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
|---|---|
| 적용범위 | This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute. This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations). |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 57 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 5840-3:2021 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques | 2021-01-21 | 표준 |
| 2 | ISO 5840-3:2021(REDLINE) | Cardiovascular implants -- Cardiac valve prostheses -- Part 3: Heart valve substitutes implanted by transcatheter techniques | 2021-01-21 | 표준 |
| 3 | ISO 5840-3:2013 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques | 2013-03-04 | 구판 |
| 4 | ISO 5840-3:2021/DAmd 1 | Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1 | 초안 |
ISO 5840-1:2021/DAmd 1 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1 상세보기
ISO 5840-2:2021/DAmd 1 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1 상세보기
ISO 5840-3:2021/DAmd 1 - Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1 상세보기
ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements 상세보기
ISO 5840-2:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes 상세보기
ISO 27186:2020 - Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements 상세보기
ISO 5840-2:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes 상세보기
ISO/TR 11633-2:2021 - Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 2: Implementation of an information security management system (ISMS) 상세보기
ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements 상세보기
ISO 13606-4:2019 - Health informatics — Electronic health record communication — Part 4: Security 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
