Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QMSR
Plan and document gamma irradiation sterilization validation for medical devices with this editable procedure. It addresses product families, dose establishment, dose mapping, bioburden, verification-dose studies, routine monitoring and dose audits, with references to the ISO 11137 series.
Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.
Supplied as one editable Microsoft Word document in a digital download.
Gamma dose establishment and validation activities
The Gamma Irradiation Sterilization Validation Procedure includes instruction on dose mapping, bioburden, sample selection, sample item portion (SIP), microbiological testing, verification dose, confirmatory verification dose experiments, dose audits, dose augmentation, routine monitoring, and establishing product families. The Gamma Irradiation Sterilization Validation Procedure applies to medical devices sterilized by gamma irradiation in accordance with ISO 11137.
The revised procedure addresses ISO 11137-1:2025 and ISO 11137-2:2013 with Amendment 1:2022, together with applicable microbiological testing references.
Sterilization dose and dose-distribution activities
Product-family qualification and routine monitoring
Contract sterilizer responsibilities and validation records
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
For load preparation, processing-record review and release, see the Sterile Load Preparation and Release Procedure. The four-procedure Medical Device Sterilization Procedure Bundle also includes this gamma validation procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read EO and Gamma Sterilization: Validation, Product Adoption and Load Release for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Medical Device Sterilization Procedure Bundle. Explore the bundle for the related documents.
