The EN IEC 60601-2-31 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the features and test methods for the safety and performance of external pacemakers with an internal power supply. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN IEC 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.
This standard specifies the basic safety and performance requirements for external pacemakers powered by an internal electrical power source. The minimum safety requirements described in this standard provide a practical level of safety in the operation of external pacemakers with an internal power supply. However, this standard does not cover the dangers inherent in the intended physiological function of the medical equipment covered. In addition, this standard does not cover implantable parts of actively applicable medical equipment and external pacemakers connected directly or indirectly.
The main changes made in the last revision of the mentioned standard are as follows:
Our organization also provides safety and performance testing services for external pacemakers with internal power supplies ( EN IEC 60601-2-31) to businesses as part of our laboratory services .
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