Reference number
ISO 10993-13:2010
International Standard
ISO 10993-13:2010
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Edition 2
2010-06
Preview
ISO 10993-13:2010
44050
недоступно на русском языке
Опубликовано (Версия 2, 2010)
Последний раз этот публикация был пересмотрен в  2019. Поэтому данная версия остается актуальной.

ISO 10993-13:2010

ISO 10993-13:2010
44050
Язык
Формат
CHF 96
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Тезис

ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers.

ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.

Общая информация

  •  : Опубликовано
     : 2010-06
    : Рассылка краткого отчета о пересмотре [90.60]
  •  : 2
  • ISO/TC 194
    11.100.20 
  • RSS обновления

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