Medical devices intended for home use: what are the requirements of EN 60601-1-11 ?

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Electrical security requirements for medical electrical devices and systems for home healthcare environments are defined in the first edition of IEC 60601-1-2 and are still not widely known. This collateral standard is used jointly with the general standard EN 60601-1 on the electrical security for medical electrical devices.

The aim of this Webinar is to give an overview of the major impacts related to the special requirements applicable to medical electrical devices and systems for home healthcare environments.

The following topics will be addressed :

• Regulatory context
• Fields of application and definitions
• Additional requirements introduced by EN 60601-1-11 and their impact on design, testing, documentation and marking

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