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Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
| 분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
|---|---|
| 적용범위 | This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 51 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 5840-2:2021 | Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes | 2021-01-21 | 표준 |
| 2 | ISO 5840-2:2021(REDLINE) | Cardiovascular implants -- Cardiac valve prostheses -- Part 2: Surgically implanted heart valve substitutes | 2021-01-21 | 표준 |
| 3 | ISO 5840-2:2015 | Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes | 2015-09-11 | 구판 |
| 4 | ISO 5840-2:2021/DAmd 1 | Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — 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 5840-3:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques 상세보기
ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements 상세보기
ISO 5840-3:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques 상세보기
ISO 27186:2020 - Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements 상세보기
ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements 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
AAMI SW91(2018 Edition) - Classification of defects in health software 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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