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With product innovation comes market immaturity and

24 Feb 2017
With product innovation comes market immaturity and, as regulations and standards tend to follow technology development, the wearable device market is facing a regulation black hole. Consequently, the mismatch of definitive global regulations and standards to this evolving technology is leaving manufacturers, retailers, and their customers vulnerable to potential safety risks.

Manufacturers and retailers could be compromising both the quality and safety of their products because they rely on off-the-shelf electronic components, not expressly designed for wearable use. For example, to take advantage of this burgeoning market, some manufacturers are simply enhancing existing traditional products, such as jewellery and clothing. However, this is a complex process which changes the compliance requirements, and therefore requires a new approach to designing and testing a product.

There is also an increasing trend for wearables to be assembled from unique combinations of components and materials. As the wearable market is so immature, specific wearables compliance requirements are still emerging, and there is insufficient information available to assess how well standard components in previously unused applications will perform in a new wearable application.

We would therefore advise manufacturers and retailers to take a ‘safety beyond compliance’ approach to the test and certification of wearables. Going beyond what any current regulations or standards dictate will help to prove that you have performed the necessary due diligence to bring a safe product to market. This should include seeking expert advice regarding any marketing claims associated with their product, especially any “medical” claims.

A comprehensive suite of tests to evaluate the safety and reliability of wearables should include:
Battery lifecycle
Bio-compatibility
Chemicals and other hazardous materials
Data security
Electrical safety
EMC
Mechanical
SAR
Wireless

A TÜV SÜD white paper, “Wearable devices: Safety beyond compliance”, examines the potential safety and reliability aspects for wearable devices, and the types of testing that manufacturers should consider in their effort to bring safe and reliable wearables to market.
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