Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Sterile Load Preparation and Release Procedure provides instruction preparing sterile loads, inspection of loads pre and post sterilization, and the requirements to release sterile loads for commercial distribution.

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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.

Sterile Load Preparation and Release Procedure Overview

The Sterile Load Preparation and Release Procedure includes everything you need to organize, process and accept sterile loads within your facility for multiple sterilization methods (e.g. EO, Gamma).

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.

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.