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

Classification and definition of medical devices

Wireless medical device export

Deeplight Technology | Assisted Hunan customers in completing testing and certification of medical device safety regulations, EMC environmental performance, cytotoxicity, allergenicity, skin irritation, etc

Medical beauty equipment products, as one of the strictest areas of supervision in various countries, involve the safety of human use and are the most direct safety issue. Before being launched, they undergo a series of rigorous testing and certification.

With the close cooperation of our team of over 20 people, this medical device project has been fully communicated and coordinated step by step. After a series of complex tests, the content involved is complex, there are many test items, the test cycle is long, and the content includes:

(1) Testing and certification of medical electrical equipment safety for products

GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety"

(2) Testing and certification of electromagnetic compatibility of products

Test standard YY 0505-2012 "Medical electrical equipment - Part 1-2: General safety requirements and parallel standards: Electromagnetic compatibility requirements and tests"

Conduct radiation field measurement tests below 1GHz, electrostatic discharge immunity test, radio frequency electromagnetic field radiation immunity test, and power frequency magnetic field immunity test

(3) Testing and certification of product environmental suitability

The testing standard GB/T 14710-2009 "Environmental Requirements and Test Methods for Medical Electrical Appliances" groups the climatic environment according to product characteristics, and conducts tests on high and low temperature storage, transportation environment, etc.

(4) Testing and certification of product performance

Conduct operational, validation, and functional tests based on the product technical requirements written by the manufacturer, and determine whether they meet the requirements.

(5) Testing and certification of laser product safety

Test standard GB 7247.1-2012 "Safety of laser products - Part 1: Equipment classification and requirements"

(6) Compile pre evaluation opinions on technical requirements for medical device products

(7) Biocompatibility testing certification

A. Cytotoxicity testing

GB/T 16886.5-2017

B. Sensitization test

GB/T 16886.10-2017

C. Skin irritation test

GB/T 16886.10-2017

After 2-3 months of debugging and rectification, we finally assisted Hunan customers to complete all necessary test projects. Deeplight standard technology has completed relevant test certification for many medical equipment and beauty product enterprises. The products involve forehead temperature gun, pulse oximeter, pulse detector, laser hair generating cap, heartbeat monitor, etc. We have accumulated rich test experience and know where failures often occur in various test projects, We can provide valuable prior experience for our clients and welcome them to consult us.