BS EN ISO 11137 is a series of international standards that discusses radiation for sterilization of health care products. BS EN ISO 11137-2 is the second part that outlines methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6.
BS EN ISO 11137-2 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
BS EN ISO 11137-2 defines product families for sterilization dose establishment and sterilization dose audit.
BS EN ISO 11137-2 on establishing the sterilization dose is useful for:
Methods 1 and 2 and the associated sterilization dose audit procedures use data derived from the inactivation of the microbial population in its natural state on the product. The methods are based on a probability model for the inactivation of microbial populations. The probability model, as applied to bioburden made up of a mixture of various microbial species, assumes that each such species has its own unique D10 value.
BS EN ISO 11137-2 guideline assists you with definition, maintenance of product families for dose setting, dose substantiation, sterilization dose auditing, selection of product for establishing the sterilization dose, testing of the product for establishing the sterilization dose, method vdmax — substantiation of 25 kGy or 15 kGy as the sterilization dose, sterilization dose audit, and worked examples for establishing the sterilization dose. BS EN ISO 11137-2 also provides two methods namely “dose setting using bioburden information” and “dose setting using fraction positive information from incremental dosing to determine an extrapolation factor” for establishing the sterilization dose for health care products.
BS EN ISO 11137-2 will support you in establishing the sterilization dose properly and the methods provided will give reliable results that are comparable to other laboratories.
BS EN ISO 11137-2:2015 supersedes ISO 11137-2:2012, which has been withdrawn. BS EN ISO 11137-2:2015 has some technical changes with respect to ISO 11137-2:2012. These include:
EN ISO 11137-2:2015
ISO 11137-2:2013