The conformity of wearable devices

As part of the Internet of Things (Internet of Things), a sector that is rapidly gaining popularity is that of “wearable devices” .
It is all those electronic devices, often equipped with radio technology, that can be worn and generally contribute to quality of life.

The emerging market for wearable devices includes smartwatch, fitness bracelets, glasses for virtual reality, devices for the health and well-being, but also products commonly not tied to these technologies, as garments and clothing accessories.

Manufacturers, importers and distributors of such devices can be found in the face of some difficulties when it comes to ensuring the safety of products they place on the market.
The companies entering this sector are not always familiar with the regulations regarding electronic devices and in some cases tend to neglect them or apply them incorrectly.
This unfortunately can have consequences on the health of end users, but also on legal aspects regarding privacy.

Penalties for non-compliance of a product are actually quite high, because a few years can affect not only the producer, but all parties in the distribution chain and sales.
It is therefore not unusual that for a single model does not conform fines come in clusters.

It is therefore necessary to consider as a whole the device to be marketed, identifying potential risk factors and applying all the necessary measures to ensure product safety.

The new challenges

Weareable device

The recent spread of wearable devices introduces more complexity in the design phase in order to ensure the quality and safety of products.
The introduction of new technologies into products is a complex process that requires careful planning since its preliminary stages, both because the components and electronic systems often used are not designed for use in wearable devices, and because it is often difficult to determine a priori all of the potential conditions to which the device may be subjected.
The wearable products, that have as their purpose the user's health and wellbeing, They may come within the physician and therefore require specific certification of medical devices.

To draw up the EU declaration of conformity They must be evaluated the safety and reliability of the wearable devices.
The samples must be subjected to a series of tests including:

  • electrical safety testing, to ensure that the user is protected from the risk of electric shock or burn related to the overheating of the electronic parts;
  • radio test, to verify the functionality of wireless communications devices that integrate WiFi, Bluetooth, etc.;
  • electromagnetic compatibility tests, to ensure that the product does not create interference to neighboring devices and which is not sensitive to disturbances;
  • testing of human exposure to electromagnetic fields, to evaluate the impact of the electromagnetic energy generated by the wireless devices on the human body.
    In the specific case of wearable products, it is the measure of SAR (Specific Absorption Rate) that relate to the percentage of electromagnetic energy absorbed by the human body when this is close to radiofrequency devices.

Manufacturers, as primarily responsible for product compliance, They are required to implement all necessary measures to ensure the safety of marketed devices, identifying the strategies to be implemented and identifying the technical aspects of the product that could pose a risk factor.

How to obtain the CE mark?

The lab Sicom Testing providing manufacturers, importers and distributors the necessary support to safely enter the market wearable devices that integrate the latest technologies, offering pre-compliance services, testing, CE certification of products, as well as post-production and batch control.

To request more information on this topic, write to
or call +39 0481 778931.

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