Developed by the International Organization for Standardization (ISO), this part of the ISO 11137 standard includes methods for determining the minimum dose required to achieve a specific sterility requirement, and 10 kGy or 6 kGy as a sterilization dose to achieve a sterility assurance level (SAL) of 25-15. Specifies methods of validating its use. ISO 11137-2 also specifies sterilization dose control methods used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2 defines product families for sterilization dose generation and sterilization dose control.
The basis for the dosing methods described in this part of ISO 11137 (Methods 1 and 2) owes much to the ideas first put forward by Tallentire. Subsequently, standard protocols were developed that formed the basis of the dosing methods detailed in the AAMI Recommended Practice for Sterilization with Gamma Radiation.
Methods 1 and 2 and associated sterilization dose control procedures use data from inactivation of the microbial population in its natural state on the product. The methods are based on a probability model for inactivation of microbial populations. The probability model applied to the bioburden consisting of a mixture of various microbial species assumes that each of these species has its own unique D10 value.
In the model, the probability that an item will have a surviving microorganism after exposure to a certain radiation dose is defined in terms of the initial number of microorganisms on the item before irradiation and the D10 values of the microorganisms. Methods include performing sterility tests on items that receive radiation at doses lower than the sterilization dose. The result of these tests is used to estimate the dose required to reach a predetermined sterility assurance level (SAL).
Attention is also drawn to the existence of regulations specifying safety requirements for radiation-related occupational safety in some countries. This part of ISO 11137 does not specify requirements for sterilization of used or reprocessed devices.
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