What certifications are required for sensors used in medical devices

ISO-13485, CE certification. Sensors to obtain ISO-13485 (medical device quality management system used for regulatory requirements) certification, in order to be widely used to provide customers with professional services and application support in line with the requirements of medical device-related regulatory regulations and quality systems, and as Philips wearable biosensor (PhilipsbiosensorBX100) to obtain CE certification, the product can help to manage triage and clinical oversight of COVID-19 patients. Sensor, a detection device, can feel the measured information, and can feel the information, according to a certain law to transform into an electrical signal or other required form of information output to meet the requirements of information transmission, processing, storage, display, recording and control.