AAMI Adopts ISO Radiation Sterilization Guidance

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The Association for the Advancement of Medical Instrumentation today announces the official adoption of a key international guidance document related to radiation sterilization.

The guidance document, entitled ANSI/AAMI/ISO 13004:2022; Sterilization Of Health Care Products—Radiation—Substantiation Of Selected Sterilization Dose: Method VD_max^SD, is a newly adopted American version of a pre-existing standard produced by the International Standards Organization (ISO).

ANSI/AAMI/ISO 13004:2022 applies to sterility assurance, a key part of the sterilization of medical devices. The document’s guidance directly applies to industrial sterilizers and is important to the work of healthcare delivery organizations.

The standard establishes a method for ensuring that a sterilization dose selection results in a sterility assurance level of 10^-6 or less for radiation sterilization used on medical devices. It also specifies a method of sterilization dose audit that can show the effectiveness of the verified sterilization doses.

The newly adopted guidance is meant to be used with ISO 11137-1 Sterilization of health care products, and makes several major changes to existing guidance. The standard:

• Cancels and replaces ISO/TS 13004:2013.
• Determines sample item portions for materials like powders, liquids, and gels.
• Has been reworded to match language in ISO 11137-2.
• Adds additional guidance on when to re-substantiate sterilization dose based on bioburden shift.

AAMI’s Radiation Sterilization Working Group helped make this ISO adoption a reality. The working group has produced many of AAMI’s radiation sterilization guidance documents, and is co-chaired by Elaine Daniell of EDan-SA LLC Consulting and Niki Fidopiastis, director of microbiology at Medtronic’s Global Laboratory Services.

This adoption is a substantive next step in support of AAMI’s mission of promoting the safe and effective use of healthcare technology and promoting optimal patient outcomes. International harmonization efforts and the use of guidance documents from groups such as ISO is a key part of this project.

Questions about getting access to the standard or its contents? Reach out to the AAMI Standards team at standards@aami.org.