Ссылочный номер
ISO 10993-1:2003
ISO 10993-1:2003
Biological evaluation of medical devices — Part 1: Evaluation and testing
Версия 3
2003-08
В время отменен
ISO 10993-1:2003
37875
Отозвано (Версия 3, 2003)

Тезис

ISO 10993-1:2003 describes

  1. the general principles governing the biological evaluation of medical devices;
  2. the categorization of devices based on the nature and duration of their contact with the body;
  3. the selection of appropriate tests.

It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.

Other parts of ISO 10993 cover specific tests.

Общая информация

  •  : Отозвано
     : 2003-08
    : Отмена международного стандарта [95.99]
  •  : 3
  • ISO/TC 194
    11.100.20 
  • RSS обновления

Жизненный цикл

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