The DIN EN 60601-1-2:2022 standard, published by the German Institute for Standardization (DIN), specifies the general requirements for the basic safety and essential performance of medical electrical equipment. This standard is an adjunct to the primary IEC 60601-1 standard and focuses specifically on electromagnetic disturbances, providing detailed requirements and test methods to ensure that medical devices operate safely and effectively in the presence of electromagnetic interference (EMI).
This edition incorporates the amendments from IEC 60601-1-2:2014 and its subsequent amendment A1:2020, ensuring that the standard remains up-to-date with the latest technological advancements and regulatory requirements. The standard is applicable to a wide range of medical electrical equipment and systems, including those used in hospitals, clinics, and home healthcare settings.
Key aspects covered by DIN EN 60601-1-2:2022 include immunity to electromagnetic disturbances, emission limits, and the verification of compliance through rigorous testing procedures. The standard aims to minimize the risk of electromagnetic interference affecting the performance of medical devices, thereby safeguarding patient safety and ensuring the reliability of medical equipment in various environments.
Compliance with this standard is essential for manufacturers seeking to market their medical electrical equipment within the European Union, as it aligns with the requirements of the Medical Devices Regulation (MDR) and other relevant directives. The standard also provides guidance for testing laboratories and certification bodies to evaluate the electromagnetic compatibility (EMC) of medical devices.
*** Please note: This description may not be accurate, please refer to the official documentation.
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