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ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

ISO 11137-1:2006 does not:

  • specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
  • detail specified requirements for designating a medical device as sterile;
  • specify a quality management system for the control of all stages of production of medical devices;
  • specify requirements for occupational safety associated with the design and operation of irradiation facilities;
  • specify requirements for the sterilization of used or reprocessed devices.


Общая информация 

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2006-04
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 198 Sterilization of health care products
  • ICS
     :
    11.080.01 Sterilization and disinfection in general

Приобрести данный стандарт

Формат Язык
PDF
Бумажный
  • CHF166

Приобретены также другие

  • ISO 11137-2:2013
    Sterilization of health care products
    Radiation
    Part 2: Establishing the sterilization dose
  • ISO 11137-3:2017
    Sterilization of health care products
    Radiation
    Part 3: Guidance on dosimetric aspects of development, validation and routine control

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цель устойчивого развития

3
Хорошее здоровье и благополучие

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 11
  6. 11.080
  7. 11.080.01
  8. ISO 11137-1:2006