Sterilization is a critical step in ensuring the safety of medical devices before they reach patients. Among various techniques, gamma irradiation stands out, governed by ISO 11137 standards. This method effectively eliminates microorganisms, safeguarding against infection risks. Manufacturers must adhere to rigorous sterilization protocols to uphold patient safety and regulatory compliance.
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What is ISO 11137?
The international standard ISO 11137 governs the use of radiation to sterilize healthcare products. It’s divided into three sections, each of which covers a different aspect of medical device radiation sterilization:
ISO 11137-1 details protocols for validating and controlling the radiation sterilization process, particularly using Cobalt 60 and Cesium 137, the predominant gamma-emitting isotopes in medical device sterilization.
ISO 11137-2 outlines procedures for determining the minimum radiation dose needed for sterilization and verifying doses of either 25 or 15 kiloGrays, measured in gamma ray emissions.
ISO 11137-3 guides manufacturers in meeting the standards of part one by detailing dosimetry’s crucial role in planning, validating, and managing the sterilization process.