ETSI EN 304 634 V1.0.0 specifies technical cybersecurity requirements and corresponding assessment criteria for personal wearable products. The standard covers connected products worn on or placed on the human body that have a health-monitoring purpose or are intended for use by or for children.

The requirements are intended to help manufacturers address cybersecurity risks associated with these products and strengthen the protection of products with digital elements against cyber threats. The standard has been developed in the context of the EU Cyber Resilience Act (CRA) and is intended to support demonstrating compliance with the relevant essential cybersecurity requirements of the CRA.

You can find the document here: ETSI EN 304 634 V1.0.0

All feedback and comments are welcome by 14 October 2026.