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Normas DIN – AENOR
DIN EN ISO 5840-1:2015-12

DIN EN ISO 5840-1:2015-12

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015 / Note: To be replaced by DIN EN ISO 5840-1 (2019-04).

Implants cardiovasculaires - Prothèses valvulaires - Partie 1: Exigences générales (ISO 5840-1:2015); Version allemande EN ISO 5840-1:2015 / Attention: À remplacer par DIN EN ISO 5840-1 (2019-04).

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 1: Allgemeine Anforderungen (ISO 5840-1:2015); Deutsche Fassung EN ISO 5840-1:2015 / Achtung: Vorgesehener Ersatz durch DIN EN ISO 5840-1 (2019-04).

Fecha:
2015-12 /Active
Equivalencias internacionales:

EN ISO 5840-1 (2015-09)

ISO 5840-1 (2015-09)

Relación con otras normas DIN:
Resumen:
This International Standard is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements. This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This International Standard outlines an approach for qualifying 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 may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This International Standard defines operational conditions for heart valve substitutes. This International Standard excludes homografts.
Keywords:
Cardiac valves, Cardiology, Chemical properties, Definitions, Design, Dimensions, Durability, Endurance tests, Evaluations, Fine mechanics, Heart, Implants (surgical), In vitro, In vivo, Inspection, Marking, Material tests, Materials, Measurement, Medical devices, Medical technology, Packages, Physical properties, Properties, Prosthetic devices, Quality assurance, Risk, Specification (approval), Sterilization (hygiene), Surgical implants, Testing, User information, Vascular prostheses, Verification
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