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Normas DIN – AENOR
DIN EN ISO 5840:2006-03

DIN EN ISO 5840:2006-03

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005); German version EN ISO 5840:2005 / Note: A transition period, as set out in DIN EN ISO 5840 (2009-08), exists until 2010-03-21.

Implants cardiovasculaires - Prothèses valvulaires (ISO 5840:2005); Version allemande EN ISO 5840:2005 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 5840 (2009-08) jusqu'à 2010-03-21.

Herz- und Gefäßimplantate - Herzklappenprothesen (ISO 5840:2005); Deutsche Fassung EN ISO 5840:2005 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 5840 (2009-08), bis 2010-03-21 beachten.

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

EN ISO 5840 (2005-12)

ISO 5840 (2005-03)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 5840:2003-07

Reemplazada por: DIN EN ISO 5840:2009-08

Reemplaza a: DIN EN 12006-1:1999-10

Resumen:
This International Standard imposes design specifications and minimum performance specifications for heart valve substitutes. It is applicable to both 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. An approach for qualifying the design and manufacture of a heart valve substitute through risk management is given. The selection of appropriate qualification tests and methods are to be 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 standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
Keywords:
Cardiac valves, Chemical properties, Definitions, Design, Dimensions, Durability, Endurance tests, English language, 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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