Тезис

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.


Общая информация 

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2008-12
    Исправленный вариант (английский)
     : 2009-03
    Исправленный вариант (Французский)
     : 2009-03
  • Версия
     : 2
  • Технический комитет
     : ISO/TC 150 Implants for surgery
  • ICS
     :
    11.040.40 Implants for surgery, prosthetics and orthotics
    11.040.99 Other medical equipment

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.040
  7. 11.040.40
  8. ISO 16061:2008