What is BS EN ISO 11137-2 - Establishing the sterilization dose about?
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.
Who is BS EN ISO 11137-2 - Establishing the sterilization dose for?
BS EN ISO 11137-2 on establishing the sterilization dose is useful for:
- Manufacturers of health care products
- Medical laboratories
- Regulatory authorities
Why should you use BS EN ISO 11137-2 - Establishing the sterilization dose?
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.
What’s changed since the last update?
BS EN ISO 11137-2:2015 supersedes ISO 11137-2:2012, which has been withdrawn.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:
- Addition of the word “and” in 9.1, second paragraph, third sentence
- Addition of the word “not” in 10.3.4.1, third paragraph
- Correction of the language used to describe requirements for interpretation of results during a verification dose experiment in the second paragraph in 7.2.6.2, 7.3.7.2, 9.2.6.3, 9.3.7.3, 9.4.6.3, and 9.5.7.3