ISO 5840-1:2021 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

Specifies general requirements for heart valve prostheses and requirements specific to full-size prostheses. Covers design, materials, durability, hydrodynamic performance, biocompatibility, and clinical investigation requirements.

Standard Details

• Standard Number: ISO 5840-1:2021
• Type: ISO Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/77034.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.