Medical Device Sterilization Procedure Bundle
SKU:
STERILE-BNDL
$399.00
$399.00
per item
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. All of the procedures comply with ISO 13485:2016, ISO 11135:2014, ISO 11137-1,-2 and -3, and 21 CFR Part 820.
- ISO 13485:2016 Compliant
- ISO 1135 Compliant
- ISO 11137 Compliant
- 21 CFR Part 820 Compliant
- MS Word Format
- Digital Product - Instant Download
Medical Device Sterilization Procedure BundleThe 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.
Medical Device Sterilization Procedure Bundle - ContentEthylene 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 provides 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.
Medical Device Sterilization Procedure Bundle - ComplianceThe Medical Device Sterilization Procedure Bundle complies with ISO 13485:2016, ISO 11135:2014, ISO 11137-1,-2 and -3, ISO 11737, AAMI 14, 19 and 28, and 21 CFR Part 820.
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