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ISO - FDIS 5840-1

Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements

pending
Organization: ISO
Publication Date: 26 June 2020
Status: pending
Page Count: 86
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
scope:

This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

This document is applicable to newly developed and modified heart valve substitutes and to 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 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ISO 5840-1 defines operational conditions for heart valve substitutes.

ISO 5840-1 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. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.

NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.

Document History

FDIS 5840-1
June 26, 2020
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This...
September 15, 2015
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
This part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840–series provide specific...

References

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