Functionality Testing

Functionality Testing is designed to determine the use life of the device by validating the instructions for use (IFU). Functionality Testing simulates the use of reusable medical device under clinical conditions and the full processing steps including repeated soiling, cleaning, disinfection, and/or sterilization exposure cycles, and validates if the device continues to function as intended at each checkpoint and at the end of testing.

Assessments could include rotation and engagement of threaded components, locking and unlocking mechanisms, etc. Throughout functionality testing, any changes to the instrumentation, including wear marks, laser marking changes, debris generation, or seizing, should be evaluated and documented. In addition to typical functionality testing, testing to failure or proof testing may be performed against a control instrument to evaluate the performance of an instrument at the beginning and end of its life cycle. The minimum number of functional cycles can be determined by reviewing the number of uses in surgeries and surgeries per month.

STEMart provides comprehensive functionality testing to help manufacturer ensure that their product remains safe and functional at the beginning, middle, and end of a device's life cycle.

Applicable Standards

• EU MDR
• FDA Guidance Document Reprocessing Medical Devices In Health Care Settings: Validation Methods and Labeling
• AAMI TIR12 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
• AAMI TIR30 (ST98) A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
• AAMI ST58 Chemical Sterilization and High-Level Disinfection in Health Care Facilities
• AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance
• AAMI ST77 Containment Devices for Reusable Medical Device Sterilization
• ISO 11135 Sterilization of Health-Care Products-Ethylene Oxide-Requirements for the Development, validation and Routine Control of a Sterilization Process for Medical Devices
• ISO 17664 Processing of Health-Care Products-Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices
• ISO 17665 Sterilization of Health-Care Products-Moist Heat-Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

STEMart helps manufacturers assess end-of-life functionality to ensure safe operation and safety throughout the life of the device. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.