IEC/EN 60601-1-2: Implications of the 4th Edition
This white paper provides a detailed overview of the fourth edition of IEC 60601-1-2:2014 and EN 60601-1-2:2015 for Medical Electrical (ME) equipment and the specific issues device manufacturers need to address ahead of the pending transition date. This edition may have a significant impact on the design, testing and documentation of many medical devices that have not met the requirements of this standard.
The transition period ends December 30th 2018, at which point both new and existing products placed on the market will have to be compliant with the new version. For the US (FDA), EU (CE Mark for Medical Devices), and Canada (Health Canada) this is the final transition date to comply with the 4th edition.
Beginning with a brief overview of the history of the standard, the paper then offers a detailed review of the significant changes and additions presented in the fourth edition including risk management immunity levels with a focus on requirements for CE marking.
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Eurofins | MET Labs is a National Certification Body (NCB) and a Certification Body Testing Laboratory (CBTL) under the international certification body scheme, (CB scheme) for testing and certification of Medical devices to IEC / EN 60601-1 for general safety and its collateral standard IEC / EN 60601-1-2 for EMC. Our test reports and certificates are recognized by over 50 countries.
