Ссылочный номер
ISO 11137:1995
ISO 11137:1995
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Версия 1
1995-03
В время отменен
ISO 11137:1995
19156
Отозвано (Версия 1, 1995)

Тезис

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of the suitability of the product for its intended use.

Общая информация

  •  : Отозвано
     : 1995-03
    : Отмена международного стандарта [95.99]
  •  : 1
  • ISO/TC 198
    11.080.01 
  • RSS обновления

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ