IEC 62353 Medical Electrical Equipment - Repeated Testing and Testing After Repair of Medical Electrical Equipment

In the IEC 62353 standard published by the International Electrotechnical Commission (IEC), test methods for the evaluation of medical electrical equipment and medical electrical systems are defined. This standard also includes repeated testing to evaluate the safety of such equipment or system parts in compliance with the IEC 60601-1 standard and its amendments, prior to commissioning, after maintenance, inspection, service and repair.

For medical equipment that does not comply with the IEC 60601-1 standard, these requirements are used taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with permissible values ​​for different versions of the IEC 60601-1 standard. For the purposes of this standard, the application of measurement methods is independent of the version of the medical equipment or medical system for which it is designed.

This standard does not apply to the assembly of medical systems. For the assembly of medical systems, the standard IEC 60601-1 applies (IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety).

The IEC 62353 standard does not define requirements for the repair, replacement and modification of medical equipment or medical systems. All maintenance, inspection, service and repair performed in accordance with the manufacturer's instructions ensures compliance with the standard used for the design of the equipment. Otherwise, compliance with applicable requirements should be evaluated and verified before tests of this standard are carried out. This standard also applies to tests after repair.

The following technical revisions have been made in the latest updates to this standard:

• Leakage current measurements based on test configurations derived from the IEC 60601-1 standard, The statement that there is an alternative method allowed is included in the informative descriptions.
• The protective earth resistance requirements for medical systems using multiple sockets have been revised to take into account the IEC 60601-1 standard regarding the safe allowable values ​​of the protective earth resistance of plugged-in equipment.
• Expected minimum insulation resistance values ​​are included in the table.
• The test sequence in Appendix B has been rearranged.

Among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors, our organization also provides repetitive testing for medical electrical equipment and testing after repair of medical electrical equipment, within the scope of IEC 62353 standard, with its trained and expert staff and advanced technological equipment. .