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Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
| 분야 | ISO/TC 150/SC 2 : Cardiovascular implants and extracorporeal systems |
|---|---|
| 적용범위 | ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements. ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1:2015 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. ISO 5840-1:2015 defines operational conditions for heart valve substitutes. ISO 5840-1:2015 excludes homografts. NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 56 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 5840-1:2021 | Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements | 2021-01-21 | 표준 |
| 2 | ISO 5840-1:2021(REDLINE) | Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements | 2021-01-21 | 표준 |
| 3 | ISO 5840-1:2015 | Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements | 2015-09-11 | 구판 |
| 4 | ISO 5840-1:2021/DAmd 1 | Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — 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
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