【Case Study】Infrared Ear Thermometer Registration in China

1. Introduction

  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.

  Working Principle:

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.

2. Classification

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.

3. Registration Unit

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.

4. Clinical Trials

Animal Test or Small Sample Test: not required

Clinical Trials: not required

In ‘Medical Device Catalog Exempted from Clinical Trials’

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. 

5. Technical Requirements

  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:

Otoscope

Table 1. Relevant Product Standards

Standard Number

Standard Name

GB 9706.1—2007

Medical electrical equipment - Part 1: General requirements for safety

GB/T 14710—2009

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

GB/T 16886.5—2003

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

GB/T 16886.10—2005

Biological evaluation of medical devices - Part 10: Stimulation and delayed hypersensitivity test

YY/T 0466.1—2009

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

YY 0505—2012

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

YY/T 0664—2008

Medical device software software life cycle process

YY/T 0708—2009

Medical Electrical Equipment - Part 1 - 4: Safety General Requirements Parallel Standard: Programmable Medical Electrical System

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation)

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