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It’s time for your Annual Radiation Sterilization Assessment

With the beginning of the New Year comes the responsibility of reviewing your present radiation sterilization process.  One of the most commonly overlooked parts of this assessment is the annual review of product family groupings.  After four (4) quarters of dose audits, the standards require a review of your established (and documented) product family grouping. You can reduce your required testing by using product family groupings; however, this also increases your risk and reduces your ability to detect changes in other members of the product family. This annual review ensures a formal process is implemented, and captures any possible changes that could lead to a change in microbial load and thus affect your sterilization effectiveness.

It’s important to ensure that the product selected to represent each family is still appropriate.  ANSI/AAMI/ISO 11137-2:2013/(R)2019 – Sterilization of healthcare products—Radiation— Part 2:  Establishing the sterilization dose, section 4.4.1 states:


Review shall be performed at a specified frequency to ensure that product families and product used to represent each product family remain valid. Responsibility for reviews of product and/or processes that might affect membership of product families shall be allocated to competent personnel. Such a review shall be performed at least annually.”


The primary aim of the review is to ensure that any changes to the product or manufacturing process, that can impact the basis on which the product family was established, be defined and determined; and if needed, redefining the selection of product that originally established the product family.

What are these possible changes that need to be reviewed?

The product selected for testing within the product family needs to continue to demonstrate that the bioburden is comprised of similar numbers and types of microorganisms. Attention to all product-related variables that could potentially contribute to bioburden will need to be reviewed. This includes raw materials, components, product design, and anything associated with the manufacturing of the product (location, equipment, environment, etc.).  If identified changes indicate a shift in bioburden, it may result in the need for a new product family definition or the selection of a different representative product.

At Nelson labs, with our expert advisory group, we can help perform these reviews and provide a formal assessment to meet the requirements set forth in the standard.  Additionally, if you need help with your initial product family grouping we have experts on hand.  For further assistance or questions please contact [email protected]