Тезис

ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.

ISO/TS 19218-1:2011 is not intended to be used to decide whether an incident is reportable or not.


Общая информация 

  • Текущий статус
     : Отозвано
    Дата публикации
     : 2011-05
  • Версия
     : 1
  • Технический комитет
     : ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices
  • ICS
     :
    03.120.10 Quality management and quality assurance
    11.040.01 Medical equipment in general

Жизненный цикл

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  2. Интернет-магазин
  3. Каталог стандартов
  4. МКС
  5. 03
  6. 03.120
  7. 03.120.10
  8. ISO/TS 19218-1:2011