No disponible en español

Estado : Publicado

Formato Idioma
PDF + ePub
PDF + ePub + versión comparada
Papel
  • CHF194
Convertir Franco suizo (CHF) a tu moneda

Resumen

This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.

This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.

This document establishes an approach for verifying/validating 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 can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.

This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

Standard first page

Preview 

Previsualice esta norma en nuestra Plataforma de navegación en línea (OBP)

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2021-01
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 51
  • Comité Técnico :
    ISO/TC 150/SC 2
    ICS :
    11.040.40 
  • RSS actualizaciones

Ciclo de vida

Objetivos de Desarrollo Sostenible

Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
Good Health and Well-being

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

  2. Tienda
  3. Standards catalogue
  4. TC
  5. ISO/TC 150/SC 2
  6. ISO 5840-2:2021