Reference number
ISO 16061:2008
© ISO 2024
ISO 16061:2008
Instrumentation for use in association with non-active surgical implants — General requirements
Edition 2
2008-12
Retirada
Retirada (Edición 2, 2008)

Resumen

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.

ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.

With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

Informaciones generales

  • Estado
     : Retirada
    Fecha de publicación
     : 2008-12
    Versión corregida (en)
     : 2009-03
    Versión corregida (fr)
     : 2009-03
    Etapa
    : Retirada de la Norma Internacional [95.99]
  • Edición
     : 2
    Número de páginas
     : 19
  • Comité Técnico :
    ISO/TC 150
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