Verification the 25-kgy dose using the iso standard iso/tr 13409 for the production of bone grafts

The purpose of this work was to verify the 25 Gy dose using the ISO standard ISO/TR 13409 for the production of bone grafts from the Tissue Bank ORTOP of the Complejo Cientifico Ortopedico Internacional Frank Pais. We performed two principal microbiological activities: bioburden estimate, pre-sterilization count plus a compensation for the efficiency of the recovery method, by ISO 11737-1 and test of sterility by ISO 11737-2. The techniques for Bioburden estimation could be direct or indirect. Choice of direct vs. indirect depends on number of contaminating micro-organisms, product configuration, ability to remove microbial contamination, effect of removal method on microbial viability, types and location of micro-organisms, nature of product and culture conditions. For a test of sterility, he product unit or SIP putted direct immersion in educated culture medium and incubate. Keep precaution to minimize level to the false positives is necessary