ISO DIS 5840-1
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
|Publication Date:||14 January 2019|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
ISO 5840 is applicable to: newly developed and modified heart valve substitutes; the accessory devices, packaging, and labelling required for their implantation; and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840 outlines an approach for verifying/validating
ISO 5840 defines operational conditions for heart valve substitutes.
ISO 5840 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices.
NOTE: A rationale for the provisions of ISO 5840 is given in Annex A.