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Normas DIN – AENOR
DIN EN ISO 5840-2:2014-06

DIN EN ISO 5840-2:2014-06

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO/DIS 5840-2:2014); German version prEN ISO 5840-2:2014 / Note: Date of issue 2014-05-30

Implants cardiovasculaires - Prothèses valvulaires - Partie 2: Valves cardiaques de substitution implantées chirurgicalement (ISO/DIS 5840-2:2014); Version allemande prEN ISO 5840-2:2014 / Attention: Date de parution 2014-05-30

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz (ISO/DIS 5840-2:2014); Deutsche Fassung prEN ISO 5840-2:2014 / Achtung: Erscheinungsdatum 2014-05-30

Fecha Anulación:
2015-12 /Withdrawn
Equivalencias internacionales:

ISO/DIS 5840-2 (2014-04)

prEN ISO 5840-2 (2014-04)

Resumen:
This International Standard is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. This International Standard is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labeling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. This International Standard outlines an approach for qualifying the design and manufacture of a surgical 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 surgical 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 surgical heart valve substitute. This International Standard defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For novel surgical heart valve substitutes (e. g., sutureless), the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis. This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. 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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