New products are flooding the market that can be worn by and/or played with by the user.This new category of products, known as “Wearables” and “Playables”, necessitate
additional product safety considerations due to their proximity to the human body. These
products present several new areas of compliance for Consumer Electronics
manufacturers to consider. This includes:
- Personal Protective Equipment: At the very least, you do not want any damage to
the product to lead to an injury hazard to the user (i.e. broken glasses causing an
eye injury). Devices worn more frequently and designed accordingly have the
potential to provide a benefit to the user, providing increased protection from
external injury hazards. For example, smart glasses can be designed and certified to
also serve as safety glasses. Smart gloves can provide finger and hand protection.
The European Union’s CE Directive for PPE is one example of new fields of
compliance that some consumer electronics manufacturers are facing.
- Ingress Protection: Wearable products can be exposed to all types of weather
conditions including dust and heavy rain. Products exposed to weather conditions
are required to have an IP rating for international certification. The IP rating system
indicates the severity of dust and water that a product can withstand without ingress.
An IP rating is provided in the format of IPXX, where the 1st “X” is replaced by a
number representing the level of protection from solid objects, the highest rating
being for fine dust protection. The 2nd “X” is replaced by a number representing the
level of protection from water, with the highest ratings being for hard jetted water and
immersion. For example, a product with an IP rating of IP22, has a low level of
protection against solid objects and water. While a product IP rated IP56 has a high
level of protection.
- Flammability of Materials: Fabrics and other combustible materials used in the
construction of wearable electrical products should be flame resistant. Conductive
materials can be tested according to EN16812 to determine their linear resistance.
Reducing resistance helps reduce heat generated in the material which helps
minimize the risk of fire.
- Lithium Battery Concerns: Wearable products are typically powered by lithium
batteries. Lithium batteries present an increased risk of fire. Also consider that
lithium batteries, even when used within their ratings, can get hot to the touch –
location on the body and insulation from the heat should be a consideration when
determining where to locate the battery in wearable or playable products.
Electric Field Exposure: Electric fields emitted by electrical products in close
proximity to the human body, especially the head, are a concern. Products are
typically SAR tested (Specific Absorption Rate) to determine the effect on the user.
- Biocompatibility: Appliances in contact with a user’s skin should be made of
materials that have been tested for biocompatibility. ISO10993, a medical device
standard on biocompatibility, is the leading standard for this purpose.
become very common. Manufacturers of such products need to be concerned with
the brightness level of their LED lighting, especially for LED’s aimed at or near the
eyes. IEC/EN62471 covers the photobiological safety of lamps and should be used
to insure brightly lit wearables are safe for the eyes.
- Washability: Wearablesandplayablesgetdirtyandthemethodofcleaningmustbe
considered in the design of these devices. Water and other liquid cleaning products
can get inside the product leading to shock or fire hazards. Designers of electrified
fabrics must consider the effect of putting the product through multiple cycles in a
clothes washer and dryer.
- Foreseeable Misuse: For consumer electronics, with products produced in large
quantities with many different users, it is a good idea to prepare a Risk Assessment
during the product development process. A Risk Assessment can help insure that
you are adequately mitigating all product hazards to a level that the manufacturer
feels is an acceptable risk exposure level. All Risk Assessments should include a
review of foreseeable misuse. With wearables, the user’s experience with the
product can lead to misuse – products that get too warm or weigh too much can be
reasons for misuse that should be considered when preparing a Risk Assessment.
YES, there is a lot to consider!
CertifiGroup Can Help
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