<p>ISO/TS 13409:2002 describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1 000 colony-forming units (cfu) that are manufactured in small quantities (less than 1 000 product units).</p>
<p>This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations:</p>
<ol><li>a single batch of product units;</li><li>initial production of a new product while the sterilization dose is being established by another method;</li><li>routine production of small batches.</li></ol>
<p>Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995.</p>
Registration number (WIID)
36708
Scope
<p>ISO/TS 13409:2002 describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1 000 colony-forming units (cfu) that are manufactured in small quantities (less than 1 000 product units).</p>
<p>This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations:</p>
<ol><li>a single batch of product units;</li><li>initial production of a new product while the sterilization dose is being established by another method;</li><li>routine production of small batches.</li></ol>
<p>Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995.</p>
