SIST EN ISO 5840-2:2021/A1:2025 PDF
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 8
- Дата публикации:
- 3 апреля 2025 г.
- Издание:
- ISO 5840-2:2021/Amd 1:2025
- ICS:
- 11.040.40
Abstract
Overview
SIST EN ISO 5840-2:2021/A1:2025 is a key European amendment to the international standard ISO 5840-2:2021, developed under the collaboration of ISO Technical Committee ISO/TC 150 and CEN Technical Committee CEN/TC 285. This amendment, approved in March 2025, focuses on cardiovascular implants specifically related to surgically implanted cardiac valve prostheses. It provides essential updates for the design, testing, and labeling requirements crucial for ensuring the safety, performance, and reliability of heart valve substitutes used in surgical implantation.
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