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JJG 1162-2019 English PDF

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JJG 1162-2019: Clinical Electronic Thermometers
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Basic data

Standard ID JJG 1162-2019 (JJG1162-2019)
Description (Translated English) Clinical Electronic Thermometers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A54
Classification of International Standard 17.200
Word Count Estimation 26,213
Date of Issue 2019
Date of Implementation 2020-03-31
Issuing agency(ies) State Administration for Market Regulation

JJG 1162-2019: Clinical Electronic Thermometers

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Clinical Electronic Thermometers National Measurement Verification Regulations of the People's Republic of China Medical electronic thermometer Published on December 31,.2019 2020-03-31 Implementation Issued by the State Administration of Market Supervision and Administration Verification Regulation of Medical Electronic Thermometer Centralized unit. National Temperature Measurement Technical Committee Main drafting unit. Zhejiang Institute of Metrology Zhejiang Founder Calibration Co., Ltd. China Jiliang University Participated in the drafting unit. Fujian Institute of Metrology Joint Logistics Support Force Drug Instrument Supervision and Inspection General Station Zhejiang Jiantuo Medical Instrument Technology Co., Ltd. This regulation is entrusted to the National Temperature Measurement Technical Committee for interpretation The main drafters of this regulation. Shen Caizhong (Zhejiang Institute of Metrology) Zhou Lianqin (Zhejiang Institute of Metrology) Cheng Yingshu (Zhejiang Founder Calibration Co., Ltd.) Chen Le (China Jiliang University) Participating drafters. Lin Jun (Fujian Institute of Metrology) Li Yongxue (General Support Station for Drug Instrument Supervision and Inspection of Joint Logistics Support Force) Yunhua Ren (Zhejiang Jiantuo Medical Instrument Technology Co., Ltd.)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Terminology (1) 4 Overview (1) 5 Measurement performance requirements (2) 5.1 Indication error (2) 6 General technical requirements (2) 6.1 Appearance (2) 6.2 Temperature display range (2) 6.3 Temperature display resolution (2) 6.4 Prompt function (2) 6.5 Maximum hold function (3) 6.6 Memory function (3) 6.7 Automatic shutdown function (3) 7 Control of measuring instruments (3) 7.1 Verification conditions (3) 7.2 Verification items (4) 7.3 Verification method (4) 7.4 Processing of verification results (7) 7.5 Verification period (7) Appendix A Reference Format for the Original Record of Medical Electronic Thermometer Verification (8) Appendix B. Medical Electronic Thermometer Verification Certificate (Inner Page) Format (13) Appendix C. Notification Form (Inner Page) of the Verification Results of Medical Electronic Thermometer (14) Appendix D Examples of Uncertainty Evaluation of Indication Errors of Medical Electronic Thermometers (1) (15) Appendix E Examples of Uncertainty Evaluation of the Indication Errors of Medical Electronic Thermometers (2) (18) Appendix F. Reference function table of standard platinum resistance thermometers at (30 ~ 45) ℃ as specified by the.1990 international temperature scale (twenty one)

Introduction

This regulation is based on GB/T 21416-2008 "Medical Electronic Thermometer" and OIMLR115 (1995 version) Medical electronic thermometer with maximum value display device (Clinicalelectricalthermometerswithmaximum device), the scope, terminology and appearance requirements of OIMLR115 are modified, and a standard instrument is used for verification The temperature field distribution requirements of the device and thermostat are consistent with OIMLR115, and refer to ASTME1112-00 (2018) "Standard Specification for Electronic Intermittent Measurement of Patient's Body Temperature" ThermometerforIntermittentDeterminationofPatientTemperature) and JIST1140- 2014 "Electronic thermometer" and other standards were formulated. This regulation is issued for the first time. Verification Regulation of Medical Electronic Thermometer

1 Scope

This regulation is suitable for intermittent measurement of body temperature of different parts of the human armpit, mouth, rectum, etc., and has the maximum value The first verification, follow-up verification and in-use inspection of the contact-type medical electronic thermometer that maintains function.

2 Reference documents

This regulation refers to the following documents. JJG 130-2011 working glass liquid thermometer JJG 161-2010 Standard mercury thermometer For dated reference documents, only the dated version applies to this regulation; for non-date quoted documents The latest version (including all amendments) is applicable to this regulation.

3 Terminology

3.1 Medical electronic thermometer clinicalelectronicthermometer Thermometer that uses sensors and circuits for clinical measurement of human body temperature. 3.2 Integrated medical electronic thermometer compactclinicalelectronicthermometer The temperature probe and the circuit are inseparable, and the two are closely connected into a medical electronic thermometer. 3.3 Split medical electronic thermometer assembledclinicalelectronicthermometer The temperature probe and the circuit can be separated, and the two are connected by a medical electronic thermometer. 3.4 Temperature probe temperatureprobe It consists of a temperature sensor and a temperature-sensitive jacket, etc. It is used to position the sensor at a specified position for temperature measurement.

4 Overview

Medical electronic thermometer (hereinafter referred to as electronic thermometer) is mainly composed of temperature sensor, special chip, digital display The display and other circuits and components are used to measure the temperature of the human body. According to the structure, it can be divided into one type and two types. its The working principle is. during measurement, the temperature sensor senses the measured temperature and outputs an electrical signal, and the electrical signal is input to the dedicated core After processing, the maximum value of the measured temperature during the measurement is displayed on the digital display, and the display maximum value is kept to Automatic shutdown. The typical structure of the integrated electronic thermometer is shown in Figure 1.

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