Test Equipment Calibration Requirements

Note reference numbers in parenthesis relate to specific sections of.

Test equipment calibration requirements.

Scope this procedure applies to the laboratory equipment used by the laboratory of xxx. The manufacture of medical devices makes use of various types of equipment and measuring instruments ranging from simple temperature sensors weighing balances pressure gauges micrometers for measuring dimensions to more complex ones. Reference documents 3 1 xxx quality manual 3 2 procedure for quality control 4. Then perhaps adjusting the calibration tolerance for the gauge would be a better solution.

Prescribes general requirements for the competence of calibration and testing laboratories. Standard that sets compliance guidelines for calibration laboratories and measuring and test equipment. This time dependent behavior can be compared to the accuracy requirements of the particular application to determine an initial recalibration interval. If national or international standards are not practical or available the manufacturer shall use an independent reproducible standard.

Manufacturing medical devices is a highly complex process and calibration requirements according to iso 13485 mean high precision and close monitoring. Some may require certified and calibrated test equipment regardless of the project size and some may not require stringent calibration standards. A1 9 requires hardness testing equipment be calibrated at least annually. Every project and measurement job has a different calibration requirement.

Subsequently recalibration reports should include as submitted and post calibration accuracy and precision data to validate and or refine the interval. A1 4 furnace weigh scales shall be verified quarterly quarterly and calibrated annually at a minimum. Process and test equipment requirements. A1 5 requires minimum annual calibration of dewpointers 3 gas analyzers spectrometers ad combustion analyzers.

The acceptable values of calibrations where the test equipment is at the 4 1 ratio would be 96 to 104 units inclusive. These requirements may not be explicitly stated which is why you must review the specs before the test. This is verified by an independent accrediting body operating under iso17011. If the calibration is performed at 100 units the 1 standard would actually be anywhere between 99 and 101 units.