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【Case Study】Infrared Thermal Imaging System Registration in China

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1. Introduction

Product Name: Infrared Thermal Imaging System, Medical Infrared Thermograph, Thermal Texture Maps System, Infrared Fluorescence Positioning Observation Camera

Product Composition: Generally, it consists of an infrared camera, a processing system, a stand and a display screen. The thermal image of the human body is marked by infrared photography.

Working Principle: The infrared radiation of the human body is collected by a thermal imaging system and converted into a digital signal to form a pseudo color heat map.

Mechanism of ActionNot Applicable

2. Classification

Classification Code: 06-13-01 Class II Thermal Infrared Imager

3. Registration Unit

1) In principle, the attachment of active medical devices and the host used for connection shall be declared as the same registration unit. For the separately registered medical device management accessories, the accessories with different expected USES are divided into different registration units in principle, and the active and passive accessories are divided into different registration units in principle. If the active and passive attachments are in the same aseptic package, they are in principle divided into the same registration unit.

2) Different types of medical devices with the same scope of application, product performance and structural composition are divided into the same registration unit in principle. However, if the models differ greatly in terms of application, performance, and structure, they are classified into different registration units.

4. Technical Requirements

1. Basic technical performance

1.1 Working band: 8μm~14μm, tolerance ±20%.--Infrared band emitted by human body

1.2 Instantaneous field of view: better than 1.1mrad.--The instantaneous field of view is the light receiving angle or observation field of a single detector in the sensor. This area is the smallest unit that the sensor can resolve. The smaller the IFOV, the smaller the minimum resolvable unit and the higher the spatial resolution of the image. The IFOV depends on the size of the sensor optics and detector.

1.3 Field of view: 20º(HX15º(V, tolerance ±20%; - The field angle determines the field of view of the optical instrument. The larger the field angle, the larger the field of view and the smaller the optical magnification. In other words, the target object will not be captured in the lens beyond this angle.

1.4 Working distance: 0.6m~5m.

1.5 Image field period: 60Hz, tolerance ± 2Hz .--Infrared camera camera sampling frame frequency, the number of samples extracted from continuous signals and composed of discrete signals per second

1.6 Warm-up time: The image generation time is not more than 60s, and the time for ensuring the accuracy of temperature measurement is not more than 30min.

1.7 Focusing function:

The system has a manual focus adjustment function, which can adjust the image to the clearest target within working distance.

2. Temperature measurement performance

2.1 Temperature measurement range: 10 ° C ~ 42 ° C;

2.2 Temperature measurement accuracy: δ ≤ 0.4 ° C;

2.3 NETD: 0.1 ° C;

2.4 temperature measurement repeatability: σ ≤ 0.2 ° C;

Table 1 Relevant Product Standards

Standard Number

Standard Name

GB 9706.12007

Medical electrical equipment - Part 1: General requirements for safety

GB/T 1912008

Packaging, storage and transportation icon

GB/T 147102009

Medical electrical environment requirements and test methods

YY/T 03162016

Medical device risk management for medical devices

YY 05052012

Medical electrical equipment - Part 1-2: General standard for safety. Parallel standard: Electromagnetic compatibility requirements and testing

YY/T 0466.12009

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1: General requirements

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation)

5. Clinical Trials

Clinical Trials: not required for the following

In ‘Medical Device Catalog Exempted from Clinical Trials’

06-13-01 Thermal Infrared Imager

Generally, it consists of an infrared camera, a processing system, a stand and a display screen. The thermal image of the human body is marked by infrared photography.

6. Registration Cost and Duration

Product Testing :

Test items

Testing duration

Testing fee(USD)

Safety Performance

60 working days





1) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

2) Administrative Approval

20 working days


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