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Medical Equipment Calibration Requirements
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Medical equipment calibration detects and fixes the inaccuracies in your equipment’s yielded results and brings them within the acceptable range of precision.
Sooner, or later, the components of machines will deteriorate in accuracy. Every equipment’s mechanism tends to wear out as time passes and as a result, its overall performance becomes compromised.
Most medical machines are calibrated by a specialist within laboratories while calibrating smaller equipment can be done in-house.
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What is Calibration?
Medical equipment calibration refers to the detection of your healthcare devices’ defects, whereas equipment maintenance refers to the removal of a fault within the equipment. Different devices and instruments need various calibration processes. Medical manufacturers provide built-in calibration process systems and a tolerance limit measurer. If your device fails its tolerance limit test, it must not be used for any process.
Proper calibration is vital in the medical device industry and must be performed regularly. Calibrating your medical equipment is critical in producing precise and accurate results.
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Procedures and Instructions
The equipment manufacturer is responsible for developing the proper procedures for their products’ routine calibration. The procedure must contain tolerance limits that help determine whether or not the device is fit for medical use. When the calibration fails, the procedure must guide how to meet the acceptable range of accuracy.
Medical equipment manufacturers should also provide documents explaining what to do if the machine fails the calibration.
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Documentation and Records
Proper documentation is vital when calibrating your equipment. To ensure that your device is calibrated properly, you must regularly schedule calibration sessions and document the process.
The records should also contain:
• Equipment identification number
• Date of calibration
• Name of the calibrator
• Next date of calibration
For quality equipment maintenance, JARCET offers a broad range of calibration services to medical laboratories nationwide. Our team of certified service engineers has been trained by renowned global manufacturers to provide you with the degree of engineering solutions you deserve. If you are interested in exploring our service offerings, please feel free to fill out the form below.
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Sources:
What is Medical Device Test Equipment Calibration? – SimplerQMS
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