Forehead temperature gun detection and certification
Forehead temperature gun introduction
Forehead temperature gun is also called infrared thermometer, which measures body temperature by infrared radiation energy emitted by human body. Its working principle is to use any object above absolute zero (-273℃) to emit infrared rays. Forehead temperature gun receives infrared rays through sensor to obtain induced temperature data. Forehead temperature gun can avoid cross infection and measure temperature quickly, so it is particularly suitable for screening people with fever symptoms in places with large flow of people, safe and fast.
Because the forehead temperature gun measures temperature by absorbing energy, the forehead temperature gun will not cause harm to the human body. 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 (affected by the environment such as temperature and wind speed, and the temperature of the forehead skin exposed to the outside is unstable).

Forehead temperature gun certification

Forehead temperature gun detection and certification
Infrared thermometer (forehead temperature gun) domestic sales and export require certification including domestic test reports, EU CE certification, ROHS report, REACH report and US FCC certification.

Forehead temperature gun/infrared thermometer test items (7-10 working days)
Performance test report: temperature display range, maximum allowable error, drop resistance, cleaning, disinfection, sterilization, indication unit, detector protection cover, self-test function, automatic shutdown function, appearance and structure, technical/instruction manual. Environmental test report: climate environment reliability test, mechanical environment reliability test, transportation test reliability test, power supply voltage applicability test. Safety test report: medical electrical equipment safety test
EMC test report: radiated interference, electrostatic discharge, radiated 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 electrical appliances
GB 9706.1-2007 General requirements for medical electrical safety
YY 0505-2012 Medical electrical equipment Part 1-2 General safety requirements parallel standard 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
Submit to the Food and Drug Administration
Review registration documents
On-site quality system assessment
Apply for production license
List of domestic registration application materials
Medical device registration application form

Certificate documents

List of basic requirements for medical device safety and effectiveness, summary materials

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

Manufacturing information

Clinical evaluation materials

Product risk analysis materials

Product technical requirements

Product registration verification report

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

Applicant identity documents

Quality system assessment application documents, etc.

Our advantages
Beice Group 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 solution.