Certification mark for Fitness Trackers
Fitness Tracker is also known as Activity Tracker, Fitness Bracelet or Activity Bracelet. It involves devices or applications that record all fitness-related data and monitors the number of steps, distance travelled and calories burned. Some devices even provide information about the heart rate and the quality of sleep. In order to capture data in the long term, the Fitness Tracker is to be synchronized with computers or smart phones. These electronic devices are worn directly on the body and thus fall into the field of portable technology, the so-called "Wearable Technologies".
Basis of certification:
The certification mark is awarded within the framework of voluntary testing and certification. It demonstrates that the product has been tested and certified by the third-party organisation TÜV SÜD. The certification mark is only affixed to products that undergo inspection by TÜV SÜD Product Service and comply with the criteria quoted below.
Key words of the certification mark:
Periodic surveillance and/or monitoring of the manufacture of a product constitutes the basic premise for certification that includes the award of a certification mark. Certification always requires product testing and regular factory inspections.
As a third-party expert organisation, TÜV SÜD Product Service verifies that the manufacturer is able to maintain consistent quality in line with the requirements throughout high-volume production and has established the necessary quality system, including incoming goods inspections, lists of materials and final product testing.
In addition, calibration of the necessary measuring and monitoring equipment must be ensured. Surveillance and/or monitoring covers the testing of safety-critical components and other materials used. If unauthorised changes are made to the product, the certificate will become invalid and the TÜV SÜD certification mark may no longer be used.
The voluntary TÜV SÜD certification mark with the statement “Safety tested” is awarded for products indicating that the product was tested and certified by the independent third-party organisation of TÜV SÜD Product Service for conformity with the essential technical safety requirements.
The product has been tested for the user against possible harmful chemicals. For example: Nickel, which may cause adverse skin reactions.
The resistance of the products is checked, when they bounce to a free fall from a normal height.
The statement “Usability” refers to comprehensive voluntary testing (user-friendliness, durability, operating instructions) carried out on the product.
The product and its operating instructions were tested for user-friendliness according to the standard developed by TÜV SÜD Product Service. As the customer expects a long service life, this statement may only be made if the product successfully passed durability testing.
Water-resistant (IP 67, IP 68, 5 ATM or 10 ATM) (optional)
The Ingress Protection (IP) class system rates the degree of protection offered by an enclosure for electrical equipment against solids (e.g. dust) and liquids. The characteristic numeral 6 stands for “dust tight”, meaning that there will be no ingress of dust. The characteristic numeral 7 stands for “temporary immersion” and 8 stands for continuously immersed in water under manufacturer specified conditions more server than for numeral 7, i.e. there must be no ingress of a harmful amount of water. The standard used to measure the IP level of the device is EN 60529.
5 ATM and 10 ATM indicates that under static (nonmoving) conditions at ca. 50 and 100 meters below the surface of the water the pressure of the water will not stop the function of the device. The standard used for measurement is ISO 22810.
In vitro cytotoxicity tested
A wearable device with material that comes into contact with the user’s skin is expected to perform its intended function and subjected to test for in vitro cytotoxicity (ISO 10993-5), which is to check for the presence of substances, which are generally toxic to cells.