Test Equipment Calibration Requirements

Manufacturing medical devices is a highly complex process and calibration requirements according to iso 13485 mean high precision and close monitoring.

Test equipment calibration requirements.

Some may require certified and calibrated test equipment regardless of the project size and some may not require stringent calibration standards. A1 4 furnace weigh scales shall be verified quarterly quarterly and calibrated annually at a minimum. Standard that sets compliance guidelines for calibration laboratories and measuring and test equipment. Subsequently recalibration reports should include as submitted and post calibration accuracy and precision data to validate and or refine the interval.

These requirements may not be explicitly stated which is why you must review the specs before the test. Then perhaps adjusting the calibration tolerance for the gauge would be a better solution. The principle guiding document for requirements relating to in house calibration activities is iso iec 17025 general requirements for the competence of calibration and testing laboratories. A1 5 requires minimum annual calibration of dewpointers 3 gas analyzers spectrometers ad combustion analyzers.

Prescribes general requirements for the competence of calibration and testing laboratories. Purpose this procedure specifies the schedule and requirements for calibration performance verification and maintenance of laboratory testing instruments and equipment. A1 9 requires hardness testing equipment be calibrated at least annually. This is verified by an independent accrediting body operating under iso17011.

Note reference numbers in parenthesis relate to specific sections of. The acceptable values of calibrations where the test equipment is at the 4 1 ratio would be 96 to 104 units inclusive. Reference documents 3 1 xxx quality manual 3 2 procedure for quality control 4. If national or international standards are not practical or available the manufacturer shall use an independent reproducible standard.

If the calibration is performed at 100 units the 1 standard would actually be anywhere between 99 and 101 units. 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. This time dependent behavior can be compared to the accuracy requirements of the particular application to determine an initial recalibration interval. Calibration standards used for inspection measuring and test equipment shall be traceable to national or international standards.