Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<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>
Reģistrācijas numurs (WIID)
33952
Darbības sfēra
<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>
