Estado : Retirada

Esta norma ha sido revisada por ISO 10993-1:2018

Resumen

ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of devices based on the nature and duration of their contact with the body;
  • the evaluation of existing relevant data from all sources;
  • the identification of gaps in the available data set on the basis of a risk analysis;
  • the identification of additional data sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2009-10
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 4
    Número de páginas
     : 21
  • Comité Técnico :
    ISO/TC 194
    ICS :
    11.100.20 
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