International Organization for Standardization

Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization - First Edition
 N 11137 AMD 1

Annotation

This International Standard specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. It 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.

Annexes are also included to provide supplementary information.

Facility design, licensing, operator training and factors related to radiation safety are outside the scope of this International Standard. It does not cover the assessment of the suitability of the product for its intended use. The use of biological indicators for validation or process monitoring, or the use of sterility testing for product release, are also not covered, as they are not recommended practices for radiation sterilization.

Автоматический перевод:

Стерилизация медицинской продукции - Требования к валидации и текущему контролю - радиационная стерилизация - первое издание

Этот Международный стандарт устанавливает требования к валидации, процесс управления и оперативного контроля за радиационной стерилизации медицинской продукции. Он применяется для непрерывного и периодического типа гамма-облучателей с использованием радионуклидов 60 Co и 137 CS и для облучателей с использованием пучка от электрона или рентгеновского генератора.