EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 60601-2-31 testing. This standard describes criteria and test methods for safety and performance that must be considered in the design and manufacture of external pacemakers operating with an internal electrical power source.
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 creates and transmits electrical impulses. It somehow has its own electricity grid. This system makes the heart beat faster in some cases. The problem of this warning focus in the electrical system of the heart is a condition that affects health. This is why pacemakers are used.
EUROLAB assists manufacturers with IEC EN 60601-2-31 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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