Classification

• Medical device classification: Class IIa (Annex VIII, Rule 10, EU MDR 2017/745)
• Software classification (IEC 62304): Class B

Standards Compliance

• EN ISO 80601-2-56:2017/A1:2020: Clinical thermometers – Basic safety and essential performance
• EN IEC 60601-1:2006 + A1:2013 + A2:2021: Medical electrical equipment – General requirements
• EN IEC 60601-1-2:2015 + A1:2021: Electromagnetic disturbances – Requirements and tests
• EN 60601-1-11:2015/A1:2021: Home healthcare environment requirements
• EN ISO 10993-1:2020: Biological evaluation – Risk management
• EN ISO 10993-5:2009: Tests for in vitro cytotoxicity
• EN ISO 10993-10:2013: Tests for irritation and skin sensitisation
• EN 62366-1:2015: Usability engineering for medical devices
• EN 62304:2006 + A1:2015: Medical device software – Software lifecycle processes
• EN ISO 15223-1:2021: Symbols for medical device labelling
• ISO 20417:2021: Information to be supplied by the manufacturer

Regulatory Compliance

• European Regulation on Medical Devices: EU MDR 2017/745
• Radio Equipment Directive: 2014/53/EU

Electromagnetic Compatibility (EMC): Baby FM has been tested and found to comply with the EMC requirements of EN IEC 60601-1-2:2015 + A1:2021. The device is designed for use in home healthcare environments. EMC precautions:

• Do not use the device in close proximity to other active medical equipment without verifying normal operation.
• Portable and mobile RF communications equipment may affect the device's performance.