Do you know what the requirements of the EN 60601 are?

EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance. The specific requirements vary depending on the part and edition of the standard. Below you can find an overview of the general categories of requirements covered by EN 60601:

1. General requirements: this includes fundamental principles for the electrical safety of the medical electrical device and its related performance. It covers topics such as electrical safety, mechanical safety, radiation protection, and general performance requirements
2. Risk management: EN 60601 emphasizes the importance of identifying and mitigating risks associated with medical equipment utilising ISO 14971 methodology. It requires manufacturers to follow a risk management process throughout the lifecycle and works in tandem with the risk management process to reduce risk and validate implemented risk control
3. Electrical safety: the standard sets requirements for protection against electrical hazards. It covers aspects such as insulation, earthing, leakage currents, electrical connections, and protection against electric shock
4. Electromagnetic compatibility (EMC): 60601-1-2 specifies general requirements for tests with regard to electromagnetic disturbances and for electromagnetic emissions of medical electrical equipment and medical electrical systems
5. Usability and user interface: 60601-1-6 specifies a process for manufacturers to analyse, specify, develop and evaluate usability to mitigate risks caused by usability problems associated with correct use and use errors
6. Essential performance requirements: 60601 series specifies performance criteria for medical electrical equipment. These criteria may vary depending on the specific type of device and its intended use, such as accuracy, measurement range, response time, and alarm functions
7. Software requirements: the standard addresses the specific requirements for medical software, including requirements related to software development processes, software validation, and cybersecurity

It’s important to note that the requirements of EN 60601 are detailed and comprehensive and covering a wide range of technical aspects. BSI supports the understanding of these requirements to ensure safety and performance of medical electrical equipment. When obtaining or using medical devices, it is crucial to verify that they comply with the relevant edition or part of EN 60601.

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