ISO 11137 Radiation Dose Setting – Method 2
The ISO 11137 series of standards is a pivotal set in medical device testing, specifically for the sterilization validation of medical devices. The ISO 11137-2:2019 standard focuses on the radiation dose setting and delivery using gamma irradiation or electron beam irradiation techniques. This method ensures that the sterilization process is adequate to provide a sterile product, which is critical for medical device manufacturers.
The ISO 11137-2:2019 specifies the procedure for determining the appropriate radiation dose required to achieve sterility assurance level (SAL) of at least 10-6. This standard provides a methodical approach to setting up and validating the sterilization process, ensuring that it is robust enough to meet stringent regulatory requirements.
Method 2 involves the use of a biological indicator (BI), typically spore strips or spore tubes, which are exposed to the sterilizing agent under conditions similar to those expected during commercial sterilization. The dose required to achieve sterility assurance is determined by observing the BI survival rate after exposure. This method ensures that the radiation dose is sufficient to eliminate all viable microorganisms present on a medical device.
The test setup includes placing biological indicators within the medical devices being tested, ensuring they are representative of the最难的部分<|im_start|><|im_start|>⚗️
