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.

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Classification and definition of medical devices

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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 Administration（CFDA）, 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:

Testing basis:

Clause 36.202.3 of YY 0505-2012

GB/T 17626.3-2016

6. Power frequency magnetic field immunity test

The test items are tested according to the methods and procedures specified in GB/T 17626.8-2006, and the test arrangement is as follows:

Testing basis:

Clause 36.202.8 of YY 0505-2012

GB/T 17626.8-2006

The above is a brief introduction to the EMC testing of Chinese medical device beauty products. Deeplight has completed relevant testing and certification for medical device products from many countries to enter the Chinese market.

Products related to Infrared Thermometer, Oximeter, Pulse Diagnosis Instrument, laser Hair Growth Cap, Heartbeat Monitor, etc. We have accumulated rich experience in testing, and know the frequent failures in various testing projects, which can provide valuable experience for customers. Welcome customers to consult us.