ISO 5840-1:2021/Amd 1:2025
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 4 марта 2025 г.
- Издание:
- ISO IS 5840 edition 2 version 1
- ICS:
- 11.040.40
Abstract
Overview
ISO 5840-1:2021/Amd 1:2025, titled Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1, is an important amendment to the internationally recognized standard governing cardiac valve prostheses. Developed by ISO Technical Committee ISO/TC 150 in collaboration with the European Committee for Standardization (CEN/TC 285), this update refines definitions, testing procedures, and performance criteria vital for cardiovascular implant developers, manufacturers, and regulatory bodies worldwide. The amendment ensures enhanced safety, performance, and reliability of cardiac valve prostheses used in clinical settings.
Похожие стандарты
Стандарты, упомянутые в описании