ISO 10993-6:1994
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Reference number
ISO 10993-6:1994
Edición 1
1994-07
© ISO 2024
Retirada
Retirada (Edición 1, 1994)

Resumen

Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level. The local effects are evaluated by a comparison of the tissue response caused by a test specimen to that caused by materials used in medical devices whose clinical acceptability has been established. The test methods for local effects after implantation are used to assess subchronic effects (short-term, up to 12 weeks), or chronic effects (long-term, longer than 12 weeks).

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 1994-07
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 1
    Número de páginas
     : 11
  • Comité Técnico :
    ISO/TC 194
    ICS :
    11.100.20 
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