❱❱ Wearable devices need to undergo a range of tests for function, safety and EMC before being launched onto the market and with such a variety of wearable devices on the market, the associated safety considerations need to have a high profile in the testing and validation process
see beyond compliance
to the manufacturers to prove that they have taken reasonable steps and due diligence to introduce new products to the market. Although regulations and standards
specific to wearables are under development in some jurisdictions, there are presently few standards that cover them as a complete product or that apply to components intended for use in such devices. As new regulations and standards are developed, it is unlikely that they will be fully harmonised across the world, forcing manufacturers to consider the specific compliance requirements for the markets they are targeting.
DEVICE TESTING A comprehensive suite of tests to
evaluate the safety and reliability of wearables would ideally include the following evaluations: n Electrical safety testing ensures the user is protected from the risks of electrical shock or burns associated with overheating. Such testing may include insulation resistance testing as well as high voltage and ground continuity testing. n Chemicals and other hazardous materials protects human health and the environment from potentially harmful chemicals by evaluating exposure risks to potentially irritating or harmful chemical substances. n Battery lifecycle testing verifies how long a battery can be expected to last under anticipated use conditions and typically includes cycle life testing, environmental cycle testing and calendar life testing. n Mechanical & physical testing typically includes testing to assess durability under anticipated use conditions, and susceptibility of key components to wear and tear. n Biocompatibility testing is intended to evaluate potential harmful effects that may result from prolonged contact between a wearable device and the human body. n SAR (specific absorption rate) 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. n Wireless testing is used to verify the speed, accuracy and integrity of data exchanged via wireless communication technologies, such as Bluetooth and Wi-Fi.
n Other performance testing can include testing for functionality, biometric accuracy, strength properties, resistance to abrasion, corrosion resistance, colour fastness, etc. n EMC testing is required in most jurisdictions where devices that include electrical or electronic components undergo a series of tests for electromagnetic compatibility with other devices in their immediate environment and for immunity to electromagnetic interference. Other testing can include immunity to electrostatic discharge (ESD). n Mobile applications testing evaluates software applications intended for use with wearable devices for functionality and usability. n Data security testing should cover the two aspects of confidentiality and data integrity. Confidentiality includes all aspects that have to do with data encryption. If encryption is used, it is evaluated for compliance with current safety requirements, with the evaluation of all external channels of communication (WLAN, Bluetooth, etc.). Data integrity is when transmissions are evaluated to ascertain if data can be modified during transmission, and whether there is any information leakage or disclosure to third parties
SAFETY BEYOND COMPLIANCE Some safety tests are required by regulatory authorities in certain jurisdictions while others are not. However, the lack of a regulation doesn’t absolve manufacturers of their responsibility to ensure the safety of their products. We would therefore recommend that a three- step safety-beyond-compliance strategy is implemented. n Step 1: pre-development planning In this initial stage of the assessment, a thorough design review should be conducted in order to understand the specific technologies involved and to identify potential safety and reliability concerns. Next it must be determined which
specific regulations and standards are applicable to the wearable as it has been designed. Aside from technical considerations, attention should also be given to unique requirements that may apply in intended target markets.
n Step 2: pilot evaluation This second stage of the product assessment sees the development of a formal and comprehensive test plan that identifies the recommended tests and a test sequence for the wearable device and its constituent components. Such plans can reduce the cost of test samples, since sample usage can be more carefully planned and fewer test samples damaged during testing. Once the test plan is in place, pre-
compliance testing can be conducted on a limited number of test samples. This helps to validate the effectiveness of the test plan, and may also identity additional product design changes in advance of formal compliance testing. A comprehensive risk analysis should
evaluate the likelihood and potential severity of all safety risks associated with the wearable device. This process may uncover issues not specifically addressed in applicable regulations and standards, but which may impact the safety of a given device under all anticipated use conditions. n Step 3: full product testing and certification Formal compliance testing is conducted as required by the regulations and standards applicable to the wearable device. Additional testing may also be conducted to more fully assess the device’s safety beyond regulatory compliance requirements.
FUTURE EVOLUTION The global regulatory framework that applies to wearables is still emerging, and a wide variety of regulations and standards across the world leave a potential gap in overall safety coverage that could unnecessarily expose consumers to risk. This makes it complicated for manufacturers to achieve compliance. As the wearable device market is
evolving so rapidly, there is an array of potential safety and reliability aspects that must be considered and particular tests that manufacturers should consider in their effort to bring safe and reliable wearables to market. A safety-beyond-compliance approach to
the evaluation, testing and certification of wearables can help to close that gap, making product design and development more time- and cost-efficient. EE
September 2018 /// Environmental Engineering /// 39
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