The crucial role of standards in ensuring the safety and efficacy of ARC intellicare

The implementation of standards is an integral part of product design and development and plays a key role for the safety and effectiveness of medical devices.

ISO 10993 provides a framework for the development of a biocompatibility evaluation to manage biological risk. Several tests performed on the use of ARC wearable sensors ensured the fitness of the device for human use without any potentially harmful physiological effects.
So that, ARC wearable sensors comply with biocompatibility standards (ISO10993).

As well, to prove that ARC charging station and all electronic components respect basic safety and essential performance of medical electric equipment many tests are carried out in according to IEC60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility) standards and IEC60601-1-11 (safe for home use).

Related Posts