CHAPTER 6
Regulations and Standards: Considerations for Sensor Technologies
All sensor-based devices, particularly healthcare devices, require a degree of regulation to ensure that they are electrically, chemically, biologically, and physically safe for the end user. The degree of regulation required depends on the level of risk associated with the device. Implantable devices, such as pacemakers, require more stringent regulation than a noninvasive thermometer. When developing or using health, wellness, or environmental devices, it is important to be aware of the regulations that pertain to that device and ensure that your device is compliant. ...
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