Norm

NEN-EN-ISO 5840-3:2011 Ontw. en

Cardiovasculaire implantaten - Hartklepprothesen - Deel 3: Hartklepvervanging geïmplanteerd met behulp van minimale invasieve technieken

  • Deze norm is ingetrokken sinds 18-03-2013

58,21

Over deze norm

Status Ingetrokken
Aantal pagina's 101
Commissie Chirurgische implantaten
Gepubliceerd op 01-03-2011
Taal Engels
This International Standard is applicable to all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute. This International Standard is applicable to both newly developed and modified minimally invasive implanted heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This International Standard outlines an approach for qualifying the design and manufacture of a minimally invasive heart valve substitute through risk management. 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 tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This International Standard imposes design specifications and minimum performance specifications for minimally invasive implanted heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This document does not specifically address requirements for valve-in-valve configurations.

Details

ICS-code 11.040.40
Nederlandse titel Cardiovasculaire implantaten - Hartklepprothesen - Deel 3: Hartklepvervanging geïmplanteerd met behulp van minimale invasieve technieken
Engelse titel Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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