Cardiovascular implants
BS EN ISO 5840-2:2021 pdf free.Cardiovascular implants – Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes. The requirements of Iso 14630 and ISO 14155 shall apply. Clinical investigations shall be performed for new surgical heart valve systems and expanded indications for use. For modifications of an existing heart valve system, if a determination is made based on the […]
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