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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Compilation of technical requirements document for domestic testing and certification of forehead temperature gun

To apply for domestic testing and certification of the forehead temperature gun, not only performance, EMC, environmental, safety and other tests need to be conducted, but also technical requirements need to be written according to the requirements in order to complete a complete domestic testing and certification requirement.

Deeplight has helped dozens of enterprises complete the national standard test and certification of the forehead temperature gun, and accumulated rich experience. It can not only provide document templates during the test and certification process, but also guide customers to write technical documentation.

For EMC projects that often fail during testing, our company has equipped an engineer team to assist customers in rectifying EMC testing failures, truly achieving one-stop completion of the entire project. For expedited projects, our company can help customers expedite them to a few working days.

infrared thermometer

1. Product model/specifications and their division instructions

1.1 Product Model/Specification RF-TWJ-01

1.3 Software

1.3.1 Software name: Medical infrared thermometer software

1.3.2 Software model: TWJ01-A

1.3.3 Software release version: TWJ01-A

1.3.4 Naming rules:

(1) Software version number "TWJ01-A - □ - □ (□ □ □ □ □)"

(2) TWJ01-A "is the main version number and belongs to the category of" major enhancement software update ". TWJ01 is the product model code, representing non-contact body temperature measurement for the forehead of the human body; A is the main program number, with versions from A to Z. ‘1‘ is a sub version number and belongs to the category of ‘slightly enhanced software updates‘.

(3) The second digit is the sub version number, which belongs to the category of "slightly enhanced software updates" and is updated when there are certain additions or changes to the functionality. The third digit is the stage version number, which belongs to the category of "corrective software updates". It is updated when defects are fixed or some minor changes are made that do not involve functional changes. The fourth digit belongs to "build", which is the program modification time.

1.4 Basic parameters of medical infrared thermometer

1.4.1 Display device: LCD display screen;

1.4.2 Product size: 145mm * 80mm * 40mm (length * width * height);

1.4.3 Weight: 120g;

1.4.4 Power supply voltage: DC3V.

1.5 Classification of Medical Devices

This product belongs to the 07-03 physiological parameter analysis and measurement equipment.

2. Performance indicators

2.1 Appearance and Structure

2.1.1 The appearance should be upright, the surface should be bright and tidy, and there should be no sharp edges, burrs, damage, or deformation.

2.1.2 The text and markings on the control panel should be accurate, clear, and firm.

2.1.3 The control and adjustment mechanism should be flexible and reliable, and the fasteners should not be loose.

2.1.4 Function keys should have clear markings and instructions.

2.2 Temperature test range

The temperature display range of medical infrared thermometer is 32.0 ℃ -42.9 ℃.

2.3 Maximum allowable error

2.3.1 Within the temperature display range of 35.0 ℃ to 42.0 ℃, the maximum allowable error is ± 0.2 ℃.

2.3.2 Within the temperature display range of 35.0 ℃ to 42.0 ℃, the maximum allowable error is ± 0.3 ℃.

2.4 Drop resistance

The medical infrared thermometer should comply with the requirements of 2.3.1 after being freely dropped from a vertical distance of 1m to a hard surface in three different initial postures during normal use.

If the medical infrared thermometer does not meet the specified requirements, it will stop providing temperature readings after undergoing an anti drop test.

2.5 Indication unit

2.5.1 Resolution

The resolution of the medical infrared thermometer indicator unit is 0.1 ℃.

2.5.2 Display

The numerical height of the display should be at least 5mm.

2.5.3 Reminder/alarm function

When the temperature measurement value exceeds the specified limit, the medical infrared thermometer has a sound or light prompt/alarm signal, or stops reading:

a) Power supply voltage;

b) Temperature display range;

c) Operating range of ambient temperature

2.5.4 Low voltage prompt function

When the battery level is within the range of 2.7V ± 0.2, the display screen will display a battery symbol or a red alarm signal, or "LO" will stop displaying the temperature reading.

2.6 Function

Press and hold the measurement button to turn on the device, and the display screen will fully display 1 After 5 seconds, the measurement will automatically take place, with a measurement time of approximately 2 seconds. Parameter settings: Short press the "Mode" key to switch between functions, long press the "Mode" key to enter detailed parameter settings, where Fl is the display unit for switching between ℃ and ℉, F2 is the buzzer switch setting, and F3 is the temperature correction setting.

2.7 Automatic shutdown function

The medical infrared thermometer should have an automatic shutdown function.

2.8 Mode

There are two measurement modes for medical infrared thermometers:

(1) Body temperature mode

(2) Calibration mode

2.9 Cleaning, disinfection, and/or sterilization

After cleaning or disinfecting the surface of a medical infrared thermometer with 75% alcohol, the markings on the shell should not be affected and should meet the requirements of 2.3.1.

2.10 Electrical safety performance

It should comply with the requirements of GB9706.1-2007.

2.11 Environmental testing requirements

The climate environment test should comply with the requirements of Table 1, the mechanical environment test should comply with the requirements of Group II in GB/T 14710-1993, and the transportation test should comply with the requirements of Chapter 3 in GB/T 14710-1993. The power supply voltage adaptability test should comply with the internal DC power supply requirements in Chapter 4 of GB/T14710-1993.

2.12 electromagnetic compatibility

It should meet the requirements specified in YY0505-2012.

3 Inspection methods

3.1 Working conditions

3.1.1 Normal working conditions

a) Environmental temperature: 10 ℃~40 ℃;

b) Relative humidity: ≤ 85%;

c) Atmospheric pressure: 70kPa-106kPa;

3.1.2 Laboratory reference conditions

The ambient temperature should be 23 ℃± 2 ℃, and the relative humidity should be (50 ± 20)%.

Under laboratory reference conditions, the medical infrared thermometer under testing should be tested at a blackbody temperature calibrated with an uncertainty of no more than 0.07 ℃ (coverage factor k=2). The calibration testing of blackbody should be conducted by a nationally recognized calibration laboratory and traceable to national metrological standards. The operating temperature range of blackbody should meet all the temperature ranges required for covering experimental testing requirements in this standard.

3.2 Appearance

By visual observation and tactile inspection, the results should meet the requirements of 2.1.

3.3 Temperature display range

Under laboratory reference conditions (with an ambient temperature of 23 ℃± 2 ℃ and a relative humidity of 50 ± 20% RH), a medical infrared thermometer is tested and the displayed readings are recorded. The results should meet the requirements of 2.2.

3.4 Maximum allowable error

3.4.1 Maximum allowable error test within the specified temperature display range.

Under laboratory reference conditions, the blackbody temperature should be measured according to the specified testing steps for medical infrared thermometers and their readings should be extracted. Before testing, the medical infrared thermometer should be stable for at least 30 minutes under laboratory reference conditions. Within the temperature display range of 35.0 ℃ to 42.0 ℃, the blackbody temperature is taken at three temperature points with roughly the same interval: 37.0 ℃, 39.0 ℃, and 41.0 ℃. Enter calibration mode and measure 3 times at each blackbody temperature, which should meet the requirements of 2.3.1.

3.4.2 Maximum allowable error test outside the specified temperature display range.

Under laboratory reference conditions, the blackbody temperature should be set according to the manufacturer‘s recommendations, and the medical infrared thermometer should be measured according to the specified testing steps and its readings should be extracted. Before testing, the medical infrared thermometer should be stable for at least 30 minutes (under laboratory reference conditions). Between 35.0 ℃ and

Outside the temperature display range specified at 42.0 ℃, two temperature points are set for the black body temperature at the low end and the high end respectively: 33.0 ℃, 34.0 ℃, 42.2 ℃

42.5℃。 Enter calibration mode and measure 3 times at each blackbody temperature, which should meet the requirements of 2.3.2.

3.5 Drop test

Medical infrared thermometers should freely fall onto a hard surface three times at a vertical distance of 1m, with different starting postures (using a hard wooden block of appropriate size placed flat on a hard foundation, with a density greater than 700 kg/㎡), including one drop on the probe end of the medical infrared thermometer in three directions.

After the drop test, conduct the test according to 3.4.1, and the results should meet the requirements of 2.3.1.

3.6 Indication unit

3.6.1 Resolution, display, and prompt function test

The results of visual inspection and practical operation inspection should meet the requirements of 2.5.1 to 2.5.3.

3.6.2 Low voltage prompt function

Replace the internal DC power supply of medical infrared thermometer with a DC stabilized power supply. When the voltage is reduced to 2.7V ± 0.2V, a battery symbol or red alarm signal should appear on the display screen of the medical infrared thermometer at low voltage, or "LO" should stop displaying the temperature reading. The result should meet the requirements of 2.5.4.

3.7 Functional test

The actual operation inspection should meet the requirements of 2.6.

3.8 Automatic shutdown function test

The actual operation inspection should meet the requirements of 2.7.

3.9 Mode

Operate according to the instructions and be able to operate in both body temperature mode and calibration mode.

3.10 Clean, disinfect, and/or sterilize the test according to the following steps:

a) The cleaning or disinfection liquids and tools shall be specified according to the product requirements;

b) Carefully clean, disinfect, and/or sterilize at least 20 times according to the specified procedures;

c) The impact of visual inspection on the shell markings should comply with the requirements of 2.1.2;

d) According to the test method in 2.3.1, the medical infrared thermometer is tested at the same ambient temperature and the same blackbody temperature

The fruit should meet the requirements of 2.9.

3.11 Electrical safety performance

According to the method specified in GB9706.1-2007, the inspection should meet the requirements of 2.10.

3.13 Environmental testing

According to the requirements of 2.11, the test should meet the requirements.

3.14 Electromagnetic compatibility EMC testing

The test was conducted according to the requirements specified in YY0505-2012, and the results should meet the requirements of 2.12.

The above is an introduction to the technical requirements for testing and certification of forehead temperature guns. Customers are welcome to inquire about our national standard testing and certification of forehead temperature guns.