Recovery Testing Terms

Originally Published MDDI October 2002

STERILIZATION VALIDATION

Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Process Validation: Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Verification: Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Calibration: Documented comparison, by written and approved procedures, of a traceable measurement standard of a known accuracy with another measuring device to respond to, detect, correlate, report, or eliminate any variation in the accuracyof the item being compared over an appropriate range of measurements.

Calibration Verification: Assaying of calibration materials to confirm that the calibration of an instrument, kit, or test system has remained stable throughout the reportable range for test results.

Qualification: The testing and review of a piece of equipment, system, or subsystem of a process to ensure its fitness for use.

Copyright ©2002 Medical Device & Diagnostic Industry