Classification and definition of medical devices

Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software. It can be seen that the scope of medical devices is very broad. Its main purpose is to diagnose, prevent, monitor, treat or alleviate diseases, and so on.

China compliance

Urgent! The forehead temperature gun needs to complete four major project testing and certification before it can be sold

Deeplight Standards has helped dozens of enterprises complete the national standard test and certification of the forehead temperature gun, and accumulated sufficient experience. It can not only provide document templates during the test and certification process, but also guide customers to write technical documentation.

For EMC projects that often fail during testing, our company has equipped an engineer team to assist customers in rectifying EMC testing failures, truly achieving one-stop completion of the entire project. For expedited projects, our company can help customers expedite them to a few working days.

Temperature measuring guns and forehead temperature guns are both electronic and medical products, and medical products are the most strictly controlled products in various countries. With the surge in demand, how can China obtain sales licenses? What are the testing requirements in China?

To obtain a sales license, it is necessary to undergo testing. The testing of the forehead temperature gun mainly involves four major areas, and the Deep Light standard is listed one by one. Please consult us for testing and certification fees.
Emergency approval testing category for forehead temperature gun and temperature measuring gun

The first test standard:

GB/T 21417.1-2008 
Medical infrared thermometer medical electrical equipment, skin type and ear cavity type, are mandatory testing content. Verify the accuracy of infrared testing, etc.
Summary: Mainly for performance testing.

The second test standard:

GB 9706.1-2007
Evaluate the safety of GE equipment of electronic products, such as leakage, grounding, radiation protection, etc.
Summary: Mainly conducting security testing.

Article 3 Testing Standards:

YY 0505-2012
Because the product is an electronic product, there must be electromagnetic compatibility requirements in order to protect the safety of medical electrical equipment.
Summary: Mainly conducting EMC testing.

Article 4 Test Standards:

GB/T 14710-2009
Medical electrical environmental requirements and test methods, transportation testing. Inspect the condition of the product in various environments such as heating, ventilation, and no insulation.
Summary: Mainly conducting environmental testing.

The above are all the testing requirements for the forehead temperature gun. Please contact Deep Light Standard to inquire about the testing cost. Due to the current surge in testing demand for such products, the laboratory is already at full capacity and the testing cycle may be extended.

In addition, Deeplight can also provide emergency approval and guidance services or product registration guidance services.