MedAccred Sterilization Audit Criteria Released

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MedAccred Sterilization Audit Criteria Released

15 January 2016

On December 22, 2015, three sets of audit criteria for use during MedAccred sterilization audits were published by the MedAccred Sterilization Task Group.  AC8113 MedAccred Audit Criteria for Sterilization is the baseline audit criteria and will be used in all future sterilization audits.  Two additional checklists: AC8113/1 MedAccred Audit Criteria for Radiation (Gamma & E-Beam) and AC8113/2 MedAccred Audit Criteria for Ethylene Oxide, will be applied based on a company’s scope of work.

The sterilization audit criteria draw from existing standards and regulations, such as ISO 13485, 21 CFR Part 820, ANSI/AAMI/ISO 11135, AAMI TIR 14 and ISO 10993-7, and ANSI/AAMI/ISO 11137-1, and will provide a thorough and robust verification of a company’s compliance to these standards.

The new audit criteria are a direct result of the hard work and dedication of the MedAccred Sterilization Task Group which is comprised of technical experts from Johnson & Johnson, Philips HealthTech, Stryker Corporation, Baxter Healthcare Corp., Becton, Dickinson & Co, DSM Biotech, Flextronics, and Synergy Health.

Mark Aubele, Senior Program Manager and MedAccred Sterilization Staff Engineer at the Performance Review Institute (PRI), has worked closely with the MedAccred Sterilization Task Group providing technical support and guidance.  Mark stated that “the publication of these audit criteria will now allow the industry to begin awarding MedAccred Sterilization accreditations to those companies who can demonstrate their compliance during an audit.  The Medical Device industry will be able to identify those companies who are performing the sterilization process to the standards they have now collectively established.”  Any company achieving accreditation will be listed on MedAccred’s Qualified Manufacturers List (located at

PRI’s Executive Vice President and Chief Operating Officer, Joseph Pinto, added his congratulations, “This is an important milestone for the MedAccred program.  Sterilization is a process which impacts the vast majority of medical devices so it is essential to control it effectively.  Those who have participated in the development of these new sterilization audit criteria deserve recognition for their efforts as I am sure the long term benefits to the industry will be significant.”