This standard specifies the classification, requirements, test methods and acceptance rules of electronic infrared imaging human surface thermometers. This standard applies to electronic infrared imaging human surface thermometers (hereinafter referred to as thermometers) that measure human surface temperature in a non-contact manner. GB/T 19665-2005 General Specification for Electronic Infrared Imaging Human Surface Thermometers GB/T19665-2005 Standard download decompression password: www.bzxz.net

1CS 11, 040. 55
National Standard of the People's Republic of China
GB/T 19665--2005
General specification for electronic infrared imaging thermometer of body skin2005-02-02Promulgated
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of the People's Republic of China
2005-06-01Implementation
This standard is proposed by the Standardization Administration of the People's Republic of China.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Electronic Measuring Instruments. This standard is under the jurisdiction of the China Electronics Technology Standardization Institute. This standard is drafted by the 11th Institute of China Electronics Technology Group Corporation. GB/F19665--2005
Participating drafting units of this standard: Science and Technology Quality Department of China Electronics Technology Group Corporation, China Electronics Technology Standardization Institute, and Beijing Electric Power General Hospital.
The main contributors to this standard are: Zhong Ronghuan, Sun Dianzhong, Huang Yinghua, Zhong Guo, Song Jianping, Qiu Pu, Li Ruwang, Bao Chao, Huang Fuyuan, Zhang Jianwei.
1 Scope
General specification for electronic infrared imaging human surface thermometers GB/T19665---2005
This standard specifies the classification, requirements, test methods, acceptance regulations, etc. of electronic infrared imaging human surface thermometers. This standard applies to electronic infrared imaging human surface thermometers (hereinafter referred to as thermometers) that measure human surface temperature in a non-contact manner.
2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced document, all subsequent amendments (excluding errata) or revised versions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any document without a date, the latest version shall apply to this standard. GB/R191-2000 Pictorial marking for packaging storage and transportation (ISO180:1997) GB/T2828.12003 Sampling inspection procedures for attributes Part 1: Sampling plan for batch inspection based on acceptance quality limit (AQL) (ISO180:1997) 2859-1:1999,IDI)
GB/T2829-2002 Periodic inspection counting sampling procedures and tables (applicable to the inspection of process stability)GE3174-1995PAI-D TV broadcasting technical specificationsGB/T5080.71986 Equipment reliability test Failure rate and mean time between failures under the assumption of fixed failure rate verification test plan (idtIEC60605-7:1978)
GB9706.1--1995 Medical electrical equipment - Part - General requirements for safety (id1EC60601:1988)GB/T14710-1993 Environmental requirements and test methods for medical electrical equipmentGH/T18268-2000 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use (idtIEC61326-1:1997,Amd. 1:1998)
3 Terms and definitions
The following terms and definitions apply to this standard. Electronic infrared imaging human surface temperature measuring device Electronic infrared imaging thierimoneter of body skin An instrument that passively receives infrared information emitted by the human body itself, converts it, and processes it into a visual image (also called a thermal image) to obtain the surface temperature and temperature distribution of the measured part of the human body. 4 Types and basic components of thermometers
4.1 Types of thermometers
4.1.1 According to the infrared detector used, it is divided into: - Refrigeration type electronic infrared imaging human surface thermometer: It uses a single unit, multiple unit, linear array or array device as an infrared detector. When using it, the detector should be cooled first. Common cooling methods include filling with liquid ammonia and installing a mechanical refrigerator. This type of instrument takes a long time to prepare.
一 Uncooled electronic infrared imaging human surface thermometer: uses uncooled array devices as infrared detectors, requires a temperature stabilization controller when in use, and can work after powering on. The preparation time is short (generally less than 1 min). 4.1.2 According to the speed of image acquisition, it is divided into:
一 Fast electronic infrared imaging human surface thermometer: forms and outputs images in accordance with the PAL television format of GB3174-1995 standard.
GB/T 19665-2005
一 Slow electronic infrared imaging human surface thermometer: forms and outputs images at a speed slower than the standard AL television format, such as 18 or 5s to output an image.
4.2 Basic components of the thermometer
The thermometer shall consist of the following parts:
Infrared camera
Image processing and display unit (computer-mounted dedicated processing unit can be used): Printer (if necessary):
Trolley (if necessary)!
Infrared camera branch (if necessary)
5 Requirements
5.1 General
The thermometer shall have the functions of collecting and forming thermal images, meeting the temperature measurement accuracy within the specified temperature measurement range, image analysis and processing, image storage, image call, color image printing, etc. The functions of each specific product can be tailored, but the main functions such as forming thermal images and ensuring the temperature measurement accuracy within a certain temperature measurement range shall comply with the requirements of this standard. 5.2 Basic technical performance
5.2.1 Working band
The working band used for human body surface temperature measurement ranges from one micron to tens of microns, which should be specified in the product specification. 5.2.2 Instantaneous field of view
The instantaneous field of view refers to the spatial optical angle corresponding to a single sensitive element of the detector after passing through the thermometer optical system, and the unit is mrad (mrad). The thermometer has an instantaneous field of view in both horizontal and vertical directions. Specific requirements should be specified in the product specification. 5.2.3 Field of view
The field of view refers to the maximum cone or fan-shaped optical angle of the human body that can form an effective thermal image through the thermometer, and the unit is degrees. The thermometer has a field of view in both horizontal and vertical directions, and the specific requirements should be specified in the product specification. 5.2.4 Working distance
The working distance refers to the distance at which the thermometer can form a clear, moderately sized thermal image of the measured part of the human body and can perform accurate temperature measurement. The minimum and maximum working distances should be specified in the product specification, which should generally be in the range of 0.3m to 5m. 5.2.5 Image field cycle
Fast thermometer: The image field cycle shall comply with the provisions of GB3174--1995. Slow thermometer: The image field cycle shall generally not exceed 5 s. 5.2.6 Warm-up time
The warm-up time refers to the time from the thermometer being powered on and starting the refrigeration (or filling with liquid nitrogen) to the time it takes to form a stable and clear image and to perform accurate temperature measurement.
Non-refrigerated thermometer: The image formation time shall not exceed 60s, and the time to achieve accurate temperature measurement shall not exceed 30min. Refrigerated thermometer: The image formation time shall not exceed 10min and the time to achieve accurate temperature measurement shall not exceed 30min. 5.2.7 Focusing function
The thermometer shall have a focusing function, and the image can be adjusted to the clearest for targets within the working distance during operation. 5.3 Temperature measurement performance
5.3. 1 Measurement range
Under the condition of ensuring the temperature measurement accuracy, the temperature range of the thermometer is 30℃-42℃. 5.3.2 Temperature measurement accuracy (5)
Temperature measurement accuracy refers to the difference between the temperature value measured by the thermometer and the actual temperature value of the standard surface source black body when the temperature of the standard surface source black body is fully heated. Generally, 80.4℃ is required. 5.3.3 Temperature resolution (NETD)
GB/T19665—2005
Temperature resolution refers to the temperature difference between the target and the background when the ratio of the peak signal to the root mean square noise is 1 at the output end of the target electronic filter. At this time, the observer can just distinguish the target and the background through the pattern on the display. Requirement NFTD0.1C5.3. 4 Temperature measurement repeatability (α)
Temperature measurement repeatability refers to the mean square error of the maximum temperature value given by the thermometer each time relative to the average temperature measurement value when the temperature is set to a black body for multiple measurements. Generally, α≤0.2℃. 5.3.5 Temperature measurement function (optional)
The following temperature measurement functions should be provided for the formed thermal image: -Measure the temperature at any point in the thermal image; -Measure the average temperature, the highest temperature and the lowest temperature for any rectangular (and square) area in the thermal image; -Measure the average temperature, the highest temperature and the lowest temperature for any irregular area in the thermal image; -Set the alarm temperature value. When a certain temperature in the thermal image exceeds this temperature threshold, an alarm indication will be given. 5. 4 Image processing and display (optional)
5. 4. 1 Image processing function
The thermometer can have the following image processing functions: -Image intensity processing,
-.. -Set the temperature measurement range;
~ -Positive and negative image switching:
...Dense image display:
-Description of the temperature distribution curve;
The temperature display at the mouse click.
5. 4. 2 Image file management function (optional) The thermometer can have the following image file management functions: storage and reading of images:
copying and copying images.
5. 4. 3 Morbidity data management function (if necessary) The thermometer should have the function of inputting and editing medical records and diagnostic information. 5.5 Printing function (if necessary) The thermometer can have the following printing functions:
--printing color images;
--printing average temperature, maximum and minimum temperature and temperature distribution images; printing medical record impression reports.
5.6 Trolley (if necessary) The trolley should be movable on a flat ground and reliably locked. 5.7 Bracket (if necessary)
The bracket should meet the following requirements:
The camera is fixed on the bracket reliably;
The bracket installation plane should be at a moderate height from the ground, and can be raised, lowered, tilted, swung left and right, and can be reliably locked in any working position. 5.8 Appearance
The appearance of the thermometer should meet the following requirements:
The outer surface should be clean and uniform in color, without scratches, peeling, cracks and other defects
The logo, product name, product model, and factory number are clear and correct; GB/T 19665-2005
|The control device is flexible and the connection is reliable. 5.9 Dimensions and weight
The overall dimensions and weight of the thermometer should be specified in the product specifications. 5.10 Electrical safety
The thermometer is generally powered by batteries or AC 220V. For AC 220V power supply, the protective earth impedance, continuous leakage current and dielectric strength shall meet the requirements of GB 9706.1-1995. 5.11 Environmental adaptability
The environmental adaptability requirements shall comply with the provisions of test group L in Table 1 of GB/T14710-1993. 5.12 Electromagnetic compatibility
5.12.1 Immunity
The immunity of the thermometer shall comply with the requirements of Table 1 in Chapter 6 of GR/T18268--2000. 5.13 Reliability
The mean time between failures of the thermometer shall not be less than 1500. 6 Test methods
6.1 General
The following conditions shall be met for basic technical performance tests and temperature measurement performance tests: Collimator: Provide an infinitely far conjugate target pattern. The collimator's diameter shall be larger than the entrance pupil of the system under test. Target system: The target radiation source is a surface source black body with precise temperature control, and the background radiation source is a black plate with square, circular, strip and other patterns in the middle and slits with adjustable width. The emissivity of the target and background plate shall not be less than 0.97, and the temperature uniformity shall be better than 0. 05℃
-Standard black body: used for temperature calibration, emissivity not less than 0.97, uniformity better than 0.1℃, absolute temperature value can be set between 30℃～42℃, control accuracy within ±0.1℃. Other main test equipment: oscilloscope, noise meter, impedance meter, medical equipment electrical measuring instrument, medical equipment dielectric breakdown device, pot tape measure, timer clock, etc.
The test case ambient temperature should be between 20℃～25℃, temperature fluctuation should not be greater than 0.5℃, relative For humidity 45%~75%; atmospheric pressure 86kPa~1u6kPa
--The collimator, target system, and standard surface source blackbody should be calibrated by a qualified measuring organization at specified time intervals. It is recommended to use special thermal imaging evaluation system test equipment. 6.2 Technical performance
6.2.1 Working band
The working band is mainly determined by the infrared detector. The inspection method is to check the spectral response data of the detector and other related components, which should meet the requirements specified in 5.2.1.
6.2.2 Temporal field of view
The size of a single sensitive element of the detector is 4 (horizontal direction) (vertical direction), and the equivalent focal length design value of the thermometer optical system is L. The instantaneous field of view in the horizontal direction is α/l.. The instantaneous field of view in the vertical direction is /I., which is converted into a value expressed in milli-rad (mrad). The result meets 5.2.2 6.2.3 Field of view 6.2.3.1 Select a vertical strip target plate, and the temperature difference between the target plate and the black body should be such that sufficient image contrast can be obtained. 6.2.3.2 The temperature measurement is fixed on a three-dimensional precision digital turntable, aligned with the collimator, and a clear image of the target is adjusted. 6.2.3.3 Adjust the turntable horizontally so that one edge of the target coincides with the leftmost edge of the effective field of view image of the thermometer. Record the turntable angle value. Adjust the turntable in the opposite horizontal direction so that the same side of the target coincides with the rightmost edge of the effective field of view image of the thermometer. Record the turntable angle value. The difference between the two angle values ​​is the horizontal field of view angle. Repeat the measurement three times, and the average angle value is the final result. GB/T19665—2005 6.2.3.4 The target plate with long slits is rotated 90° and the above measurement process is repeated in the vertical direction to obtain the pitch field of view angle. 6.2.3.5 The result shall meet the requirements of 5.2.3. 6.2.4 Working distance
Use a steel tape measure to measure the distance and place the selected surface source black body at the minimum and maximum working distances specified in the product specification. Turn on the machine and collect images. The thermometer can obtain clear images of the black body under test at different distances, and the temperature measurement performance is qualified. The working distance shall meet the requirements of 5.2.4.
6.2.5 Image field period
Use a pulsator or a timing clock to measure the image field period, which shall meet the requirements of 5.2.5. 6.2.6 Warm-up time
6.2.6.1 Use a timing clock to record the time from the thermometer power-on (for refrigeration type thermometers, simultaneously start the refrigerator or add nitrogen) to the appearance of a stable image on the display screen, which shall meet the requirements of image formation time in 5.2.6. 6.2.6.2 From the time the thermometer is powered on to the preheating time specified in the product specification, the temperature measurement result of the stable temperature-controlled standard black body should be within the specified temperature measurement accuracy () - that is, it meets the requirements of the guaranteed temperature measurement time in 5.2.6. 6.2.7 Focusing function
Through the focusing operation, the thermometer can clearly image the small standard within the maximum and minimum working distances, which meets the requirements of 5.2.7. 6.3 Measurement performance
6.3.1 Temperature measurement range
The standard black body source temperature is set at 30℃ and 42% respectively. When the method in 6.3.2 is used to test and meets the requirements of 5.3.2, the temperature measurement range meets the requirements of 5.3.1.
6.3.2 Temperature measurement accuracy (6
Use a standard black body source and select a temperature T within the guaranteed temperature measurement range. The temperature measuring instrument images the source within the effective working distance and adjusts the image to the maximum. After the working state is stable for 30 tuin, start the measurement. Repeat the measurement of the black body temperature N times and record the source temperature measurement value T each time. Calculate the temperature measurement accuracy according to formula (1). It should meet the requirements of 5.3.2. -,I
T, temperature of blackbody source:
T—temperature value of each measurement:
N—number of measurements.
6.3.3 Temperature resolution (NETD)
Select a square or round moon target and a background target, and set the temperature difference △T to 3°C. Align the thermometer with the collimator exit pupil and adjust a clear image of the target. Use an oscilloscope to measure the peak signal value Vs at the output end of the detector preamplifier, cover the thermometer, and use a noise meter to measure the mean square noise V2 at the same point. Calculate the temperature resolution NFT according to formula (2). The result should meet the requirements of Table 5,3.3 NETD :
Where:
NETD—temperature resolution:
AT-----temperature difference between the target and the background; V is the peak value signal at the output end of the detector preamplifier; V2 is the mean square noise behind the pupil of the hygrometer. NETI)AT
GB/T 19665--2005
6. 3.4 Repeatability of temperature measurement (μ)
Select a temperature of the standard blackbody source within the temperature measurement range to ensure accuracy, and adjust the temperature meter to the image of the reference body at the effective working distance. Keep the image stable for 30 minutes. Repeat the temperature measurement n times, record the measured value T of each time, and calculate the temperature measurement repeatability α according to formula (3) and formula (4). The result meets the requirements of 5.3.4: ST
Where:
\average temperature;
T,--the temperature value of each measurement;
n1——the number of measurements;
a—measurement repeatability,
6. 3. 5 Temperature measurement function
According to the requirements of 5.3.5, actually operate the thermometer. 6. 4 Image processing and display
6.4.1 Image processing function
According to the requirements of 5.4.1, actually operate the thermometer. 6.4.2 Image file management function
According to the requirements of 5.4.2, the actual operation of the thermometer. 6.4.3 Medical record management function
According to the requirements of 5.4.3, the actual operation of the thermometer, 6.5 Printing function
Actual operation of printing, should comply with the provisions of 5.5. 6.6 Trolley
Actual operation of the trolley, the implementation should comply with the provisions of 56. 6.7 Bracket
Actual operation of the bracket, should comply with the provisions of 5.? 6.8 Appearance
Visual and sensory inspection, should comply with the requirements of 5.8. 6.9 Dimensions and measurements
Carry out according to the provisions of the product specifications.
6.10 Electrical safety
For the thermometer powered by AC 220V, the test methods for protective ground impedance, continuous leakage current and dielectric strength shall be carried out in accordance with the requirements of GB 9706.1-1095 18), 19, 4, 20, 4 respectively. 6.11 Environmental test
6. 11.1 General
All environmental test methods shall be carried out in accordance with the provisions of GI3/T14710-1993, but the pretreatment and initial test of each test shall be cancelled. The temperature measurement accuracy shall be tested at the end of each test and shall meet the requirements of 5.3.2. 6.11.2 Rated working low temperature test
According to the provisions of 10.1 in (3/F14710-1993. The test duration is 1h. 6.11.3 Low temperature storage test
According to the provisions of 10.2 in GB/T 14710-1993. The recovery test is 8h. 6.11.4 Rated working high temperature test
GB/T 19665--2005
According to the provisions of 10.3 in GB/T117101993. The thermal equilibrium time is 1h, the running test duration is 4h, 6.11.5 High temperature storage test
According to the provisions of 10.4 in GB/T 14710-1993. The recovery time is 4 1.6.11.6 Rated working damp heat test
According to the provisions of 10.5 of GB/T14710-1993. The test duration is 4h. 6.71.7 Damp heat storage test
According to the provisions of 10.6 of GB/T14710-1993. The test duration is 48h. 6.11.8 Vibration
According to the provisions of 10.7 of GB/T 14710-1993, the test direction is vertical. 6.12 Electromagnetic compatibility
6.12.1 Immunity
According to the provisions of Chapter 6 of GB/T18268-2000, the test results shall meet the requirements of Table 2\Continuous monitoring operation\Performance criteria. 6. 13 Reliability
Reliability test shall be carried out in accordance with the provisions of GB/T5080.7. The specific test plan shall be specified in the product specification, and the results shall comply with the provisions of 5.13.
Inspection rules
7.1 Inspection classification
Inspection is divided into finalization inspection, acceptance inspection and type inspection. 7.2 Finalization inspection
Finalization inspection is an internal inspection used by the quality inspection department of the manufacturer or the higher-level competent department to assess whether all product performance meets the design requirements. Finalization inspection shall cover all requirements specified in Chapter 5. The number of samples and implementation plan for finalization inspection shall be specified in the product specification. 7.3 Acceptance inspection
7.3. 1 General
The acceptance inspection is conducted by the quality department of the manufacturer to inspect its products, or by the user (receiving party) to inspect the products produced by the contractor (delivering party).
7.3.2 Inspection items
The acceptance inspection items shall be in accordance with the provisions of Table 1.
Table 1 Acceptance inspection items
Ding band
Shun time field of view
Working distance
Inspection items
Medical imaging cycle
Warm-up time
Focus function
Requirements Article number
Inspection method Article number
CB/T 19665--2005
Windsor of the Continent
Test Item F
Measurement Accuracy
Temperature Resolution
Source Measurement Repeatability
Temperature Measurement Function
Image Processing Function
Image File Management Function
Medical Record Data Management Function (When Necessary)
Printing Function (When Necessary)
Taiwan Military (When Necessary)
Standard (When Necessary)
7.3.3 Sampling Plan
Qiu 1 (Continued)
Requirement No.
Test Method No.
Sampling Plan According to the provisions of GB/T 2828.1, the inspection level is the general inspection level IL=Ⅱ·Qualified Quality Level AQI.-4, and the sub-normal inspection sampling plan is selected
7. 3.4 Inspection batch
An inspection batch is composed of one production batch or several production batches that meet the following conditions: using basically similar materials, correct processes and equipment, etc.; the time interval between production batches should not exceed three months. 7.3.5 Qualification judgment
According to the results of sample inspection, if the number of unqualified products found in the sample is less than or equal to the qualified judgment number, the batch is considered a qualified batch; if the number of unqualified products found in the sample is greater than or equal to the unqualified judgment number, the batch is judged to be unqualified. 7.3.6 Handling of unqualified products
The handling of unqualified products shall be carried out in accordance with the provisions of 7.3 of GB3/T2828.1-2003. 7.4 Type inspection
7.4.1 General
7.4.1.1 Type inspection The quality inspection department of the contractor or the higher-level competent department shall periodically take samples from the products of continuous batch production for inspection to determine whether the production process can ensure the continuous and stable product quality. 7.4.1.2 Type inspection shall be carried out in the following cases: - Before the production of new products (including the conversion of old products); - Products in continuous production shall be inspected at least once a year; - When the production is resumed after more than one year; - When there are major changes in design, process or materials, or when the national quality supervision department makes a request. 7.4.2 Inspection items
Type inspection items shall be in accordance with the provisions of Table 2.
7.4.3 Sampling plan
Inspection items
Electrical safety
Environmental test
Table 2 Type inspection items
Requirements Article No.
GB/T 19665—2005
Inspection method Article No.
Inspection samples shall be taken from the batches that have passed the batch inspection. The sampling plan shall comply with the provisions of B/T2829. The unqualified quality level is RQI.-30, the discrimination level is D1.-I, and a single sampling plan is selected. 7.4.4 Qualification judgment
If the number of unqualified products found in the sample is less than or equal to the qualified judgment number, the batch is judged to be qualified; if the number of unqualified products found in the sample is greater than or equal to the unqualified judgment number, the batch is judged to be unqualified. 7. 4.5 Treatment after type inspection
Treatment after type inspection shall be carried out in accordance with the provisions of 5.12 of GB/T2829-·2002. 8 Labels and instruction manuals
8. 1 Labels
Each thermometer shall be fixed with a label in an appropriate and obvious position, and the label shall contain the following information: Manufacturer name:
Product name and model;
Power supply voltage and frequency.
Product registration number; bzxz.net
Product factory number:
Date of manufacture.
8.2 Instruction Manual
The instruction manual shall include the following contents: product registration number;
product specification number;
detailed description of the thermometer's main performance, scope of use, installation, usage method, temperature calibration cycle, maintenance and other precautions;
description of various signs and symbols;
-Safety instructions;
-Related instructions on the thermometer's use for human body oxygen measurement. 8. 3 Inspection Certificate
The inspection certificate shall include the following contents: manufacturer's name!
product name and model;
-product factory number:
-Inspection date;
-Inspector code.
9 Packaging, transportation, storage
9.1 Packaging
9.1.1The outer packaging box shall be able to ensure that the product is not damaged by nature, and the box shall be equipped with rainproof, moisture-proof devices and soft tree pads. GB/T19665—2005
The accompanying documents, accessories, etc. shall be packed in a neutral material packaging bag and placed in a conspicuous position in the packaging box. The infrared camera shall be packed separately.
The packaging shall have the following marks:
Name and address of the manufacturer:
-Product name and model number;
-Product registration number;
Gross weight, net weight;
Volume (length x width x height), unit: mm
Date of manufacture.
The marking shall comply with the provisions of GB/T191.
The transportation method and requirements of the thermometer shall be specified by the product specification or in accordance with the provisions of the order contract. 9.3 Storage
The storage environment of the packaged product shall be a well-ventilated and clean room with a temperature of 40℃～55℃, a relative humidity not exceeding 90%, no corrosive gas, and good ventilation.
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