NF EN 552/A1

<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 ⁶⁰Co or ¹³⁷Cs, 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>

<p>ISO 11137-2:2006 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level (SAL) of 10^-6. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.</p> <p>ISO 11137-2:2006 defines product families for dose establishment and dose auditing.</p>

<p>ISO 11137-3:2006 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.</p>