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.
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:
Ce document spécifie les exigences concernant la validation, la maîtrise du procédé et la surveillance de lastérilisation des dispositifs médicaux par irradiation.
Le présent document modifie les annexes A et B.
Le présent document modifie le paragraphe 4.2.1 b), pour résoudre les différences dans l'interprétation des prescriptions techniques concernant l'établissement de la dose stérilisante.
<p>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.</p> <p>ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide <sup>60</sup>Co or <sup>137</sup>Cs, a beam from an electron generator or a beam from an X-ray generator.</p> <p>ISO 11137-1:2006 does not:</p> <ul><li>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;</li><li>detail specified requirements for designating a medical device as sterile;</li><li>specify a quality management system for the control of all stages of production of medical devices;</li><li>specify requirements for occupational safety associated with the design and operation of irradiation facilities;</li><li>specify requirements for the sterilization of used or reprocessed devices.</li></ul>
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