Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QMSR
The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The Gamma Sterilization Validation Procedure applies to all medical devices sterilized by gamma radiation per ISO 11137.
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Gamma Irradiation Sterilization Validation Procedure
The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The gamma sterilization validation procedure applies to all medical devices sterilized by gamma radiation per ISO 11137-1:2025, ISO 11137-2:2013 with Amendment 1:2022 and ISO 11137-3:2017.
Gamma Irradiation Sterilization Validation Procedure Overview
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.
Regulatory framework
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.
