Medical Device Sterilization Procedure Bundle

The Medical Device Sterilization Procedure Bundle includes QMS procedures related to EO and Gamma Sterilization Validation and Monitoring, Sterile Load Preparation and Release, and Environmental Controls.

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Medical Device Sterilization Procedure Bundle - Content

Ethylene Oxide (EO) Sterilization Validation Procedure-The Ethylene Oxide (EO) Sterilization Validation Procedure defines the planning and testing requirements for conducting the validation, re-validation, adoption and routine sterilization of medical devices by ethylene oxide (EO) gas.

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.

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.

Environmental Controls Procedure- The Environmental Controls Procedure establishes the requirements for cleanrooms and controlled manufacturing environments where a cleanliness standard is intended to be met or where other requirements for the manufacture of medical devices are necessary.