Deeplight assists Chinese customers to complete the testing and certification of medical device safety regulations, EMC, environmental performance, cytotoxicity, skin irritation, etc.
Time:2022-12-20
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As one of the most stringent areas of supervision in various countries, medical beauty device products involve the safety of human use, and are the most direct safety issues. They will undergo a series of stringent testing and certification before going on the market.
Part.1 What we have experienced in testing
With the close cooperation of the teams of more than ten people on both sides, this medical device project has fully communicated with each other in case of trouble, coordinated progress step by step, and has gone through a series of complex tests, involving complicated contents, numerous test items, long test cycle, and contents as follows:
(1) testing and certification in terms of product medical electrical equipment safety
(1) testing and certification in terms of product medical electrical equipment safety
GB 9706.1-2007 Medical Electrical equipment-part 1: general requirements for Safety
(2) testing and certification in terms of electromagnetic compatibility of products
Test standard YY 0505-2012 Medical Electrical equipment-part 1-2: general safety requirements juxtaposed standard: electromagnetic compatibility requirements and tests
Carry out the radiation field measurement test below 1GHz, electrostatic discharge immunity test, radio frequency electromagnetic field radiation immunity test, power frequency magnetic field immunity test.
(3) testing and certification in terms of product environmental suitability.
According to the test standard GB/T 14710-2009 Environmental requirements and Test methods for Medical Electrical Appliances, climatic and environmental groups were carried out according to product characteristics, and high and low temperature storage and transportation environment tests were carried out.
According to the test standard GB/T 14710-2009 Environmental requirements and Test methods for Medical Electrical Appliances, climatic and environmental groups were carried out according to product characteristics, and high and low temperature storage and transportation environment tests were carried out.
(4) testing and certification in terms of product performance
According to the product technical requirements prepared by the manufacturer, carry out operational, confirmatory and functional tests, and judge whether the requirements are met.
(5) testing and certification in terms of laser product safety
(5) testing and certification in terms of laser product safety
Test standard GB 7247.1-2012 Safety of laser products-part 1: equipment classification, requirements
(6) compiling pre-evaluation opinions on technical requirements of medical device products.
(6) compiling pre-evaluation opinions on technical requirements of medical device products.
According to the national regulations, after pre-evaluation, we can see whether the product technical requirements need to be further supplemented and improved, and whether the product technical requirements need to be further supplemented and improved.
(7)Biological compatibility test certification
A. Cytotoxicity test
A. Cytotoxicity test
GB/T 16886.5-2017
B、 Sensitization test
GB/T 16886.10-2017
C、 skin irritation test
GB/T 16886.10-2017
GB/T 16886.10-2017
C、 skin irritation test
GB/T 16886.10-2017
Part.2 Conclusion
After 2-3 months, debugging and rectification, finally assist customers to complete all the necessary test projects.
Part .3 Broadcast
Part .3 Broadcast
Deeplight standard technology has completed the relevant test certification for a number of medical devices and beauty products enterprises.
The products involve frontal temperature gun, oximeter, pulse diagnosis instrument, laser hair cap, heartbeat monitor and so on. We have accumulated rich testing experience and know the frequent failures in all kinds of test projects, which can provide customers with valuable pre-experience.
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