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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

Deeplight|Introduction to EMC testing standards for medical device certification in China

 

China‘s medical device products are divided into Class I, Class II and Class III:
 
Class I is a relatively simple one, which can be put on record and tested in the Municipal Drug Administration. Such as masks and medical cotton swabs.
 
Class II, the more complicated ones that will contact the human body, such as the laser hair growth cap and the pulse oximeter, which contact but are not implanted in the human body, need to be recorded and tested in the Provincial Drug Administration (PDA).
 
The Class III category is the most complicated and needs to be filed with the China Food and Drug AdministrationCFDA, such as cardiac pacemakers, which generally involve clinical practice.
 
Deeplight now introduces the EMC testing part which mainly applies for medical registration for the Class II and Class III of products.
 
 

1
. EMC Test Basis of Medical Device Products

The application for medical registration certificate of medical devices often requires various tests, such as biocompatibility test, safety test, performance test, environmental test and EMC test.
 
It is an inevitable and important link for EMC electronic and electrical medical device products to apply for medical registration certificate.
 
According to YY 0505-2012 Medical Electrical Equipment Part 1-2: General Safety Requirements and Parallel Standards: Electromagnetic Compatibility Requirements and Tests, medical devices and products are subject to radiation field measurement test below 1GHZ, electrostatic discharge immunity test, radio frequency electromagnetic field radiation immunity test and power frequency magnetic field immunity test.
 
2. Standards of EMC Testing in China

(1) Emission measurement is based on the following standards:

Standard number
Standard name
 
YY 0505-2012
Medical electrical equipment-Part 1-2: General requirements for safety-Parallel standards: requirements for electromagnetic compatibility summation test
GB 4824-2019
Limits and measurement methods of RF disturbance characteristics of industrial, scientific and medical device
 
(2) Anti-interference test is based on the following standards
 
Standard number
Standard name
 
YY 0505-2012
Medical electrical equipment-Part 1-2: General requirements for safety-Parallel standards: requirements and tests for electromagnetic compatibility
 
GB/T 17626.2-2018
Electromagnetic compatibility test and measurement technology electrostatic discharge immunity test
 
GB/T 17626.3-2016
Electromagnetic compatibility test and test technology-Radio frequency electromagnetic field radiation immunity test
 
GB/T 17626.8-2006
Electromagnetic compatibility test and measurement technology-Power frequency magnetic field immunity test
 
3. Measurement test of radiation field below 1GHz
 
 This test item is tested in anechoic room according to the methods and procedures specified in YY 0505-2012, and the test arrangement is as follows:
 
 
Testing basis:

Clause 36.201.1 of YY 0505-2012
 
GB 4824-2019
 
4. Electrostatic discharge immunity test
 
 The test items are tested according to the methods and procedures specified in GB/T 17626.2-2018, and the test settings are as follows:
 
 
Testing basis:

Clause 36.202.2 of YY 0505-2012
 
GB/T 17626.2-2018
 
5. Radio frequency electromagnetic field radiation immunity test
 
Testing items are tested according to the methods and procedures specified in GB/T 17626.3-2016.
 
The EUT shall be tested in the anechoic room according to its specified operating state, and the test arrangement is as follows: