Glossary Term
Instrument Calibration
Definition
nstrument calibration is the process of verifying and adjusting the accuracy of a device or instrument by comparing its measurements with a known standard or reference. This ensures that the instrument consistently delivers precise and reliable results within defined tolerances.
Relevance to the MedTech Industry
Calibration is critical for maintaining the accuracy and reliability of instruments used in the medical field, ensuring compliance with regulatory standards and safeguarding patient safety. Proper calibration minimizes measurement errors, supports quality control, and ensures devices function as intended in clinical or laboratory environments.
Additional Information & Related Terms
Key Components of Instrument Calibration
Reference Standards
Calibration relies on traceable reference standards, often certified by national metrology institutions, to ensure accuracy.
Calibration Procedures
Defined processes outline how instruments are calibrated, including test points, environmental conditions, and acceptable tolerances.
Documentation
Calibration results are recorded in calibration certificates or logs, providing traceability and evidence of compliance.
Frequency of Calibration
Calibration schedules depend on the instrument’s usage, regulatory requirements, and the criticality of its measurements.
Adjustment and Recalibration
Instruments outside acceptable limits are adjusted and recalibrated to restore accuracy.
Related Terms
Quality Control: Instrument calibration is a key component of maintaining quality in medical device manufacturing.
ISO/IEC 17025: A standard specifying general requirements for the competence of calibration and testing laboratories.
Preventive Maintenance: Calibration is often part of a broader preventive maintenance strategy for medical devices.
Traceability: Ensures calibration results are linked to internationally recognized standards.