DS/EN ISO 5840-3:2013
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

Standard No.

DS/EN ISO 5840-3:2013

Release Date

2013

Published By

Danish Standards Foundation

Status

Be replaced 2021-02

Replace By

DS/EN ISO 5840-3:2021

Latest

DS/EN ISO 5840-3:2021

Scope

ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the r

DS/EN ISO 5840-3:2013 history

• 2021 DS/EN ISO 5840-3:2021 Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021)
• 2013 DS/EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques