Testing & Analysis Services

6 Criteria for Medical Devices That Need to be Calibrated

Improve Medical Devices Maintenance by Calibrating Medical Devices to Keep It Durable and Strong

In the world of health, the term calibration of medical devices is known which is very useful for testing a medical device whether it is accurate and in accordance with standards. Currently, getting high-quality medical devices or medical equipment is quite difficult.

Many rogue manufacturers are found that make medical devices that do not comply with national or international standards. In addition, the quality of medical devices will also decline from time to time. Therefore, when buying, you have to be really careful so you don’t make the wrong choice.

Even though a medical device has good quality, it may not always work optimally if maintenance is not carried out. So, periodic calibration is important to maintain the accuracy and feasibility of the equipment.

What is Calibration?

Maybe you are not familiar with the meaning of calibration of medical devices, which is an activity to determine the conventional truth of the value of the designation of measuring tools and materials.

This is done by comparing traceable measuring standards to national and international standards. This activity is important for every medical device, especially those that are routinely used (used every day) in health facilities.

Government regulations are very clear in setting the criteria for medical equipment that must be calibrated. The following are the criteria for medical equipment in health care facilities that must be calibrated at least once a year:

  1. Do not have certificates and marks of passing the testing or calibration of medical devices.
  2. The certificate has expired and has passed the test.
  3. The designation or output or performance or safety of the medical device is no longer appropriate, even though the certificate and test pass are still valid.
  4. Medical devices have been damaged and repaired, even though the certificate and test pass are still valid.
  5. Has been transferred from one agency to another, even though the certificate and test pass are still valid.
  6. If the certificate and the test pass are lost or damaged so that information from medical equipment cannot be obtained.

The criteria for medical equipment that have passed calibration and are suitable for use are as follows:

  1. The deviation value of the measurement results when compared with the value enshrined in the medical equipment does not exceed the allowable deviation value.
  2. The work safety measurement value is included in the normal/allowed threshold value.

By performing periodic calibrations, the performance and accuracy of medical devices can be maintained properly. Thus, the quality of health services to patients can also be maintained.

Why Medical Devices Need Calibration

Calibration of medical devices is an activity that must be carried out, especially when medical equipment has entered the 6 criteria mentioned above. The purpose of this calibration activity is to:

1. Ensure Conformity of Characteristics Specifications

The first objective is to ensure the characteristics of the specifications of an instrument/tool ​​or measuring material. If there is a discrepancy, then the permit or certification letter cannot be issued.

2. Determine the Deviation Value

Calibration of medical devices also aims to determine the deviation or deviation of the conventional truth from the designation value of the measuring material/instrument, as well as the deviation of the nominal dimensions that should be for a measuring material.

3. Maintain the Accuracy of the Values ​​Produced

The next goal is to maintain the accuracy of the value produced from medical devices so that the results do not deviate far from the specified threshold (according to the standard).

4. Guarantee Standardized Measurement Results

In addition, calibration will also ensure that the measurement results of a medical device are in accordance with national and international standards.

A medical device used for services at a health facility needs to be calibrated from time to time, even though it still has a certificate of eligibility. Especially if the medical equipment is widely used, the feasibility test must always be carried out.

If you want to test various medical devices, you can entrust them to Sucofindo. Sucofindo Laboratory provides medical equipment calibration services and has obtained a medical equipment test and calibration operation permit from the Indonesian Ministry of Health.

So, you don’t need to hesitate to carry out the calibration process of medical devices and leave the work to professionals to complete it.

For more information about testing and analysis services and health sector, you can read our article here. If you and your company need further information regarding our services, contact and consult about it here.

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