BS EN ISO 5840-1:2021 - Cardiovascular implants. Cardiac valve prostheses. General requirements

BS EN ISO 5840-1:2021

Cardiovascular implants. Cardiac valve prostheses. General requirements

Status : Current   Published : February 2021



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 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.

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.


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

Standard NumberBS EN ISO 5840-1:2021
TitleCardiovascular implants. Cardiac valve prostheses. General requirements
Publication Date08 February 2021
Normative References(Required to achieve compliance to this standard)ISO 14630, ISO 14971, ISO 5840-2, ISO 14937, ISO 11135, ISO 11137 (all parts), ISO 14160, ISO 22442 (all parts), ISO 13485, ISO 15223-1, IEC 62366 (all parts), ISO 14155, ISO 5840-3, ISO 10993-1, ISO 11607 (all parts)
Informative References(Provided for Information)ASTM F1830, ISO 11139, ISO 25539-1, ISO/IEC 17025, ASTM F2182, ISO 10993-4, ASTM F2119, ISO 17665-1, ASTM F2213, ASTM F2503, ASTM F2052
ReplacesBS EN ISO 5840-1:2015
International RelationshipsEN ISO 5840-1:2021,ISO 5840-1:2021
Draft Superseded By19/30385869 DC
DescriptorsValves, Labels, Performance testing, Classification systems, Risk assessment, Hazards, Heart, Physical properties of materials, Circulatory system, Prosthetic devices, Sterilization (hygiene), Cardiology, Verification, Medical equipment, Reports, Life (durability), Performance, Implants (surgical), In vivo testing, Instructions for use, Clinical testing, Design, Acceptance (approval), Packaging, Prosthesis
Title in FrenchImplants cardiovasculaires. Prothèses valvulaires Exigences générales
Title in GermanHerz- und Gefäßimplantate. Herzklappenprothesen Allgemeine Anforderungen
ISBN978 0 539 02790 7
File Size3.169 MB

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