Forehead gun introduction

The frontal temperature gun is also called infrared thermometer, which measures the body temperature by the infrared radiation energy emitted by the human body after washing hands. Its working principle is that any object will emit infrared rays when it is higher than absolute zero (-273 ℃), and the forehead gun receives infrared rays through the sensor to obtain the induced temperature data. The frontal temperature gun can avoid cross-infection and the temperature measurement is fast, so it is particularly suitable for screening people with fever symptoms in places with large flow of people. It is safe and rapid.

Because the frontal temperature gun measures temperature by absorbing energy, the frontal temperature gun does not cause harm to the human body when measuring body temperature. The advantage of the forehead temperature gun is that the measurement time is short and it does not contact the human body; the disadvantage is that the accuracy is low (because of environmental influences such as air temperature and wind speed, and the temperature of the exposed forehead skin is unstable).

Forehead gun testing and certification

Infrared thermometers (forehead thermometers) are required for domestic sales and export certification including domestic test reports, EU CE certification, ROHS reports, REACH reports, and US FCC certification.

Forehead thermometer / infrared thermometer test project (7-10 working days)

Performance test report: temperature display range, maximum allowable error, drop resistance, cleaning, disinfection, sterilization, indicator unit, detector protective cover, self-test function, automatic shutdown function, appearance and structure, technology / user manual.

Environmental testing report: climate environment reliability test, mechanical environment reliability test, transportation test reliability test, power supply voltage application ability test.

Safety test report: safety test of medical electrical equipment

EMC test report: radiation interference, electrostatic discharge, radiation anti-interference

Standard reference

Chinese Domestic Standard Reference

GB_T 21417.1-2008 Medical infrared thermometer Part 1_ Ear cavity type

GBT 14710-2009 Environmental requirements and test methods for medical appliances

GB 9706.1-2007 General requirements for medical electrical safety

YY 0505-2012 Medical electrical equipment Part 1-2 General requirements for safety Parallel standards Electromagnetic compatibility Requirements and tests

EU Standard Reference

EN 60601-1: 2006 + A1: 2013

EN 55011

EN 55014-2

Domestic testing process

product testing

Prepare registration documents

Report to the FDA

Review registration documents

On-site quality system assessment

Apply for production license

Domestic registration application information list

Medical Device Registration Application Form

Supporting documents

List of basic requirements for safe and effective medical devices, summary information

Research materials (emphasis: software verification and life cycle verification are required)

Manufacturing Information

Clinical evaluation data

Product risk analysis data

Product technical requirements

Product registration verification report

Declaration of conformity of product manuals and label samples of the smallest sales unit

Proof of the applicant ’s identity

Quality system assessment application documents, etc.

Our advantage

ZRLK has a professional testing team to provide you with professional consultation and service support, and provide a comprehensive and complete one-stop testing and certification program.