DS/EN ISO 5840-1:2021

Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements (ISO 5840-1:2021)

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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
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 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 may 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 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.

Number of pages: 92

Published: 2021-02-09

Date of approval: 2021-02-08

International relationships : EN ISO 5840-1:2021 IDT ISO 5840-1:2021 IDT

ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics

Item number: M329017



  • CEN/TC 285
  • ISO/TC 150/SC 2
  • ISO/TC 150/SC 2/WG 1

Danish committee