SIST EN ISO 5840-1:2021/A1:2025 PDF
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 3 апреля 2025 г.
- Издание:
- ISO 5840-1:2021/Amd 1:2025
- ICS:
- 11.040.40
Abstract
Overview
EN ISO 5840-1:2021/A1:2025 is Amendment 1 to ISO 5840-1:2021, adopted by CEN as a European Standard in March 2025. It updates the general requirements for cardiac valve prostheses (cardiovascular implants) and clarifies terminology, test conditions and test methods used for valve hydrodynamics, leakage, durability and pediatric testing. The amendment is intended to be implemented as a national standard across CEN member states by September 2025.
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