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  • BSI
    BS EN ISO 5840-1:2021 Cardiovascular implants. Cardiac valve prostheses - General requirements
    Edition: 2021
    $538.63
    / user per year

Description of BS EN ISO 5840-1:2021 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.

NOTE

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
StatusUnder Review
Publication Date2021-02-08
ReplacesBS EN ISO 5840-1:2015
Identical National Standard OfEN ISO 5840-1, ISO 5840-1
DescriptorsPackaging, Performance, In vivo testing, Performance testing, Verification, Medical equipment, Heart, Risk assessment, Design, Labels, Circulatory system, Prosthetic devices, Hazards, Classification systems, Valves, Sterilization (hygiene), Cardiology, Life (durability), Acceptance (approval), Prosthesis, Instructions for use, Clinical testing, Reports, Physical properties of materials, Implants (surgical)
ICS11.040.40 Implants for surgery, prosthetics and orthotics
CommitteeCH/150/2
ISBN978 0 539 02790 7
PublisherBSI
Pages88

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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