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【Case Study】Infrared Ear Thermometer Registration in China
Time : 2019-05-20 Source : CIRS Author : Shawn
◆ Product Name:
Infrared Medical Thermometer、Infrared Ear Thermometer
◆ Product Composition:
It generally consists of an infrared temperature sensor, a probe cover, a display unit, a power supply circuit, and a measurement circuit.
In the natural world, all objects above the absolute zero (-273 ° C) will radiate infrared rays, and the energy and temperature of the radiated infrared rays are proportional. Using this relationship, the temperature of the object can be calculated by measuring the infrared intensity of the object.
◆ Typical Structure:
It generally consists of a power button, a display screen, a detector and a detector cover.
Classification Code: 07-03-04 Class II
Product Description: It usually consists of an infrared temperature sensor, a probe cover, a display unit, a power supply circuit, and a measurement circuit. It provides the body temperature based on the calculation of the amount of emittance.
Expected Usage: This device uses an infrared method to measure the clinical temperature of a patient, usually detecting the temperature of the ear canal and forehead.
1. Basic principle is different
2. Differences in performance indicators
If there are large differences in performance indicators, consideration should be given to dividing into different registration units.
The infrared ear thermometer is composed of a plastic casing, a circuit board, a temperature measuring component, a display screen, a power source, a separator, etc.; it can be divided into several models according to design, technical parameters, additional auxiliary functions, and intended use; Display the body temperature of the measured human ear cavity. Clinical accuracy and clinical repeatability reports are required.
◆ Performance Index
5.1 Normal working conditions
a) Ambient temperature：16℃～35℃；
b) Relative humidity：85% or less；
c) Atmospheric pressure: 70kPa～106 kPa；
d) Use Power: a.c.220（1±10%）V, 50(1±2%)Hz;
5.2 Temperature display range
The display range is not narrower than 35.0℃～42.0℃。
5.3 Maximum allowable error
5.3.1 Maximum allowable error within the temperature display range
The maximum allowable error is ±0.2 °C in the temperature display range of 35.0 °C to 42.0 °C.
5.3.2 Maximum allowable error outside the specified temperature range
Outside the temperature display range of 35.0 ° C to 42.0 ° C, the maximum allowable error is ± 0.3 ° C.
5.3.3 Maximum allowable error under varying environmental conditions
Under varying environmental conditions, the maximum allowable error of the thermometer in the temperature range of 35.0 ° C ~ 42.0 ° C should meet the requirements of 5.3.1.
5.3.4 Maximum allowable clinical error
Clinical repeatability should not exceed the range of ±0.3 °C.
5.4 Indicator Unit
(1) The resolution of the thermometer indicating unit should be 0.1 ° C or less.
(2) The temperature value on the thermometer display is at least 4 mm in height or achieved by visual amplification.
(3) When one or more of the following data exceeds the limits specified by the manufacturer, the thermometer shall have an audible or optical cue/alarm signal, or stop providing temperature data:
a) power supply voltage;
b) Display range;
c) Operating range of the ambient temperature;
（4）Low voltage prompt function
A thermometer powered by an internal DC power supply that provides an identifiable indication or alarm signal or stops displaying temperature readings when the voltage is below the manufacturer's specified limits.
◆ Test method
For details, see: GB/T 21417.1-2008 Medical infrared thermometers Part 1:
Table 1. Relevant Product Standards
Medical electrical environment requirements and test methods
GB 15980—1995
Disposable medical supplies hygiene standards
GB/T16886.1—2011
Biological evaluation of medical devices - Part 1: Evaluation and testing in the process of risk management
Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test
GB/T 16886.7—2001
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residues
Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity test
Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1: General requirements
Medical electrical equipment - Part 1-2: Safety common requirements. Parallel standard: Electromagnetic compatibility requirements and testing
GB/T21417.1—2008
Medical infrared thermometers - Part 1: Otoscope
Medical device software software life cycle process
Medical Electrical Equipment - Part 1 - 4: Safety General Requirements Parallel Standard: Programmable Medical Electrical System
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