The IEC 60601-2-31 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), the criteria for safety and performance that should be addressed in the design and manufacture of external pacemakers powered by an internal electrical power source, and explains test methods.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-31 Electrical medical equipment - Part 2-31: Specific features for the basic safety and required performance of external pacemakers with an internal power supply.
The said standard does not include implantable parts of active applicable medical devices and external pacemakers that can be connected directly or indirectly to the supply network.
In the latest update to the IEC 60601-2-31 standard, the energy reduction test requirement has been removed, the external defibrillation exposure test has been completely revised, the exclusion of air discharges only to ESD immunity tests has been removed, and ISO 14708-2 for pacemakers and ISO 14117 for EMC. Compliance with the standard has been achieved.
A few standards that are indispensable during the implementation of the IEC 60601-2-31 standard are: IEC 60601-1-2 (assurance standard: electromagnetic disturbances), ISO 14117 electromagnetic compatibility, implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization. devices) and ISO 14708-2 (active implantable medical devices).
Unlike other organs of the body, the heart is an organ that generates and transmits electrical impulses. Somehow it has its own electricity grid. This system causes the heart to beat rapidly in some cases. This stimulation focus in the electrical system of the heart creates problems and affects health.is a situation. Pacemakers are used for this reason.
Tests in accordance with IEC 60601-2-31 standard are also carried out by our organization within the scope of medical device tests.
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