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Introduction to US-CAN regulations / Technology Alliance / Operators wireless test certification of medical device products

Time:2022-09-26 Views:412
The global spread of the COVID-19 epidemic, to some extent, has accelerated the sale of medical device products. Medical devices, as the most strictly regulated products in various countries, have a bearing on human health and safety. In addition to the FDA and CE-MDR/MDD certification on routine clinical and medical functions, there are other key testing and certification on electronic wireless.

Apart from the sensors used for monitoring and detecting the biological indications of human body, such as blood oxygen, blood pressure, and blood glucose, the medical devices also have a series of communication systems used for transmitting the data, which are used to transmit the detected data to the cloud or the database or the background monitoring center.

 A medical device product will bring along the common wide-area wireless 2G/3G/4G/5G, including the now popular internet of things 4G communication systems such as Cat.M(eMTC)/NB-IOT.

 Local wireless common WI-FI, bluetooth. For these product with wide area wireless 2G/3G/4G/5G, access to that operator‘ s network is required, and the acquisition of stable, secure, and continuous wireless resources is particularly critical. these resources ultimately point to telecom operators. therefore, medical device product with wide area wireless need to be authenticated by telecom operators.

The operator‘s certification is not a single one or two certification, but a series of certification. A ring buckle a ring, to meet the certification requirements of the operator. Serial certifications encountered with medical device products with 2G/4G+ bluetooth /WI-FI include:

Basic regulatory approvals, US FCC ID,CAN IC ID, DOE, DOC, Ca 65, and more.
The test contents include: RF test, human radiation absorption SAR test, electromagnetic compatibility EMC test, lithium battery energy efficiency test, and toxic substances test for electronic products.

Technology Alliance, Bluetooth SIG certification, WI-FI Alliance certification.
Tests include: receiver-transmitter rf signal evaluation (different from regulatory rf testing, evaluation in more detail), functional configuration testing, throughput testing, cryptographic security testing, interoperability conformance testing, etc. 

Operators alliance certification, PTCRB/GCF certification.
The test contents include: radio frequency consistency, communication protocol consistency, field test verification, air radiation performance test, card interface test, and functional test (such as short message, VoLTE, VoNR), etc.

Operators certification, T-mobile/Verizon/AT&T Certified etc. 
The test contents include: network interconnection and interworking test, existing network real network test, air interface radiation evaluation, network security verification, function stack test, equipment software evaluation, firmware upgrade test, etc.

This series of test certification, time-consuming, technical documentation requirements, difficult, the whole project done down short 1-2 months, long need to take half a year, so it is best in the product design is completed, began to prepare related test certification. From the determination of the early communication system, to the screening of the frequency band, and so on, if problems are found during the test, the problems will be improved in time and retested.

To apply for the operator‘s T-mobile/Verizon/AT&T certification, the operator needs to have the PTCRB/GCF certification in advance, and then enter the operator‘s test certification. However, to obtain the PTCRB certification ID number, the IC ID, FCC ID, WI-FI CID alliance and other certifications should be prepared in advance, and the ID number of the product should be prepared and submitted.

When the product is submitted to the operator, the software version number and the hardware version number of the product should be noticed, and when the authenticated communication module is used, the accurate firmware number should be given, and the module should be ensured to be valid.
 
Deeplight has assisted many well-known medical device manufacturers to complete the wireless sales plan in North American market.We can provide customers with a product certification plan, testing time, and certification programs in the early stage. We can combine a variety of testing advantages to provide a complete set of service solutions.

In addition, it can help customers to select communication standard and communication frequency band. Assist the customer to select the available modules, ensure the validity period of the modules, the types of modules, and whether the modules are in the operator certification list, thus speeding up the time to market of the customer‘s products.