Steps towards compliance with EN 60601

Achieving EN 60601 compliance involves several steps to ensure that your medical electrical equipment meets the safety and essential performance requirements specified by the standards. Below are the main steps towards compliance: 

1. Familiarize yourself with EN 60601: [include link to the shop] It’s important to gasp the scope, definitions, and applicable parts of the standard that pertain to your medical electrical equipment.
2. Risk Management: implement a systematic approach to risk management, as outlined in ISO 14971. Conduct a thorough risk assessment of your device, identify hazards, and implement appropriate risk control measures.
3. Identify Applicable Parts and Editions: determine the relevant parts and editions of the EN 60601 series that apply to your device based on its intended use and characteristics. Different parts cover specific types and aspects of medical electrical equipment.
4. Technical Documentation: prepare the technical documentation required for compliance. This includes any document that provides detailed information about the design and performance of the device, such as schematics, component details, mechanical design drawings, intended use statement, usability files etc.
5. Labelling and instructions for use: ensure that your devices labelling and instructions for use meet the requirements of EN 60601. This includes providing clear and comprehensive instructions for proper device operation, maintenance, and safety precautions.
6. Testing and verification: perform the necessary testing and verification activities to ensure that your device meets the specific requirements of EN 60601. This may also include additional tests if determined required by the risk management process.

It is important to note, that the steps may vary depending on the complexity and classification of your device and the specific requirements of the target markets. Speak to BSI and start navigating the EN60601 compliance process effectively.