Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QMSR
Organize sterile loads, review processing records and document release of medical devices with this editable Sterile Load Preparation and Release Procedure. It covers pre- and post-sterilization inspection, load identification, EO and gamma load controls, review of sterilization evidence and final release records.
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Supplied as one editable Microsoft Word document in a digital download.
ISO 13485:2016 Sterile Load Preparation and Release Procedure
The Sterile Load Preparation and Release Procedure governs the preparation and organization of a sterile load, the inspection of post-sterilized product, and the final release of a sterile load for commercial distribution.
The procedure provides forms and instructions to organize, process and assess sterile loads for multiple sterilization methods, including EO and gamma irradiation.
The procedure includes: sterile load data forms to properly organize a sterile load; sterile load labeling for each stage of the process to ensure load control; and includes the sterilization records (post sterilization) required for the final release of a sterile load to finished goods.
Sterile-load preparation and shipment controls
Ethylene-oxide and gamma load-control steps
Biological-indicator review, inspection and final release
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.
The revised procedure references ISO 11135:2014 for ethylene oxide sterilization and the ISO 11137 series for gamma irradiation.
Use this procedure alongside the EO Sterilization Validation Procedure or Gamma Irradiation Sterilization Validation Procedure for the applicable process. All three are included in the Medical Device Sterilization Procedure Bundle.
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.
