Medical Device Tests

Medical Device Tests

Medical devices save lives. The sooner medical devices hit the market, the sooner it helps people. However, before doing this, it is necessary to ensure medical device compatibility.

Medical Device Tests

Medical device compatibility is crucial to the success of all businesses producing medical devices. Failure to ensure compatibility compromises the future of the device. In terms of medical device compatibility, first of all, it is necessary to provide medical device safety for patients, to obtain medical device approval from regulatory agencies and to ensure that medical device controls are smooth.

People expect the medical devices used to be safe. The use of medical devices has to improve people's health and save their lives. That's why it's important to prove medical device compatibility. The ultimate goal of developing a medical device is to assist patients. If the device is unsafe, the risk of injury to patients increases.

It is easier to obtain medical device approval from legal institutions by ensuring medical device safety. Legal agencies have a number of compliance regulations to ensure that the use of medical devices is safe. These regulatory agencies also attach importance to creating quality products.

Developed by the International Standards Organization (ISO), the ISO 13485 standard focuses on medical device quality (TS EN ISO 13485 Medical devices - Quality management systems - Requirements standard for regulatory purposes). It is very important to meet these standard requirements and to get the approval of their authorized institutions in order for the device to reach the world markets.

The set of standards designed for the electrical compatibility of medical devices is as follows:

  • 60601-1 is the main safety standard for medical electrical equipment
  • 60601-1-xx series are coverage standards for medical electrical equipment
  • 60601-2-xx series are special standards for medical electrical equipment
  • 60601-3-xx series are performance standards for medical electrical equipment

A few medical device testing services provided by our organization are:

  • TS EN 60601-1 Electrical and medical equipment - Part 1: General requirements for basic safety and performance
  • TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General rules for basic safety and required performance - auxiliary standard: general characteristics, experiments and guidance for electrical medical equipment and warning systems in electrical medical systems
  • 60601-2-20 Electrical medical equipment - Part 2-20: Specific requirements for the basic safety and performance of infant transport incubators
  • TS EN 60601-3-1 Medical electrical equipment - Part 3-4: Basic performance rule for oxygen and carbon dioxide partial pressure monitoring equipment passing through the skin
  • TS EN 60601-2-54 Electrical medical equipment - Part 2-54: Special rules for the basic safety and required performance of x-ray equipment used in radiography and radioscopy

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