SIST EN ISO 5840-3:2021/A1:2025 PDF
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 9
- Дата публикации:
- 3 апреля 2025 г.
- Издание:
- ISO 5840-3:2021/Amd 1:2025
- ICS:
- 11.040.40
Abstract
Overview
SIST EN ISO 5840-3:2021/A1:2025 is an important European and international standard that specifies requirements for cardiovascular implants, particularly cardiac valve prostheses designed for implantation using . This Amendment 1 updates the original EN and reflects the latest consensus and technical advancements related to heart valve substitutes, covering newly developed and modified products, their delivery systems, packaging, labelling, and performance evaluation.
Похожие стандарты
Стандарты, упомянутые в описании