FEATURE WEARABLES & M2M SAFETY BEYOND COMPLIANCE
Bringing safe wearable devices to market can pose numerous challenges as the patchwork of emerging global regulations and standards creates complexity in achieving compliance. Designers and manufacturers must therefore think about the overall safety of their device, beyond what current regulations or standards dictate, and overcome challenges that have the potential to impact their wearable products in terms of both safety and quality, says Richard Poate, senior manager at TÜV SÜD Product Service
speed, accuracy and integrity of the information exchange between devices via wireless communications technology
Other Performance testing – other quality and performance factors may be required to maintain brand standards, or to meet customer procurement requirements in the supply chain. Such tests may include functionality, biometric accuracy, strength, abrasion and corrosion resistance, and colour fastness
Data security testing – this includes testing for confidentiality/encryption and data integrity, so that it cannot be modified during transmission
EMC testing –most countries and other jurisdictions require devices that include electrical or electronic components to undergo a series of tests for EMC with other devices in the immediate environment
M
any wearables available today are comprised of off-the-shelf
electronic systems and components, which were not expressly designed for this use. Wearables may also be assembled from unique combinations of components and materials that may not match other non-wearable applications. In both circumstances, there is unlikely to be sufficient information available to assess how well standard components, now being used in previously unused combinations, will respond to being used in wearable applications. Considerations must also be made as to
how best to address the challenge of meeting regulatory requirements and standards, which in the case of specific regulations to wearables, are few and far between. Although specific regulations are under development, there are presently few standards that cover wearables as a complete product, or that apply to components used in wearables. It is therefore up to manufacturers to prove due diligence – that they have taken appropriate actions to bring safe products onto the market.
TESTING TO EVALUATE WEARABLES A comprehensive suite of tests to evaluate the safety and reliability of wearables would ideally involve the follow evaluations:
10 JULY/AUGUST 2017 | ELECTRONICS
Electrical safety testing – helps to ensure that the user is protected from the risks of electrical shock or burns, due to overheating of electrical or electronic components. Such testing may include insulation resistance, as well as high voltage and ground continuity testing
Testing for chemicals – this evaluates exposure risks to potentially irritating or harmful chemical substances, such as lead, nickel and phthalates
Battery lifecycle testing – is used to verify how long a battery can be expected to last under anticipated use conditions. Such testing typically includes cycle-life, environmental and calendar-life testing
Mechanical testing – this helps to ensure the safety of the wearer and usually includes testing to assess durability under anticipated use conditions, and the susceptibility of key components to wear and tear
Biocompatibility testing – is intended to evaluate potential harmful effects that may results from prolonged contact between wearable device and the human body. Specific tests will depend on the type of device and its indented use
Specific Absorption Rate (SAR) testing – evaluates the amount of electromagnetic energy generated by wireless devices that is absorbed as a result of close contact with the head or body
Wireless testing – is used to verify the Figure 1:
As regulations and standards that specifically apply to wearables are still in development, there is a potential gap in overall safety for consumers
Mobile applications testing – software applications are assessed for their functionality and usability, as well as for their ability to protect personal data from cyber-attack The compliance of wearable devices should therefore follow a three-step process: 1. Pre development planning – a thorough design review to understand the specific technologies involved, and to identify potential safety and reliability concerns. This should be done early on to reduce the potential for design changes further down the line. You must then determine which specific regulations and standards are applicable to the wearable device in order to evaluate the extent of testing that will be required to achieve product certification. 2. Pilot evaluation – a formal, comprehensive test plan must be developed, which identifies the recommended tests and the test sequence for the device and its components. This eliminates, or reduces, the need for duplicate tests, and minimises the costs as fewer test samples will be required. 3. Full-scale product test and certification – depending on the wearable device, and the scope of the test plan, additional testing may also be conducted to assess safety beyond regulatory compliance requirements.
TÜV SÜD Product Service
www.tuv-sud.co.uk T: 01489 558100
/ ELECTRONICS
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