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JJG 1188-2022 English PDF

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JJG 1188-2022: Medical Leakage Current Testers
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Basic data

Standard ID JJG 1188-2022 (JJG1188-2022)
Description (Translated English) Medical Leakage Current Testers
Sector / Industry Metrology & Measurement Industry Standard
Word Count Estimation 26,242
Date of Issue 2022-12-07
Date of Implementation 2023-06-07
Issuing agency(ies) State Administration for Market Regulation

JJG 1188-2022: Medical Leakage Current Testers

---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.
National Metrology Verification Regulations of the People's Republic of China Medical Leakage Current Tester Released on 2022-12-07 2023-06-07 Implementation Released by the State Administration for Market Regulation Verification Regulations for Medical Leakage Current Tester Replace JJG 843-2007 Medical Leakage Current Tester part Responsible unit. National Electromagnetic Metrology Technical Committee Main drafting unit. Shenzhen Institute of Metrology and Quality Inspection China Institute of Metrology Participating in the drafting unit. Wuhan Longcheng Measurement and Control Technology Co., Ltd. Shandong Provincial Metrology and Testing Center Changsha Tianheng Measurement and Control Technology Co., Ltd. This regulation entrusts the National Electromagnetic Metrology Technical Committee to be responsible for interpretation The main drafters of this regulation. Gu Jianping (Shenzhen Institute of Metrology and Quality Inspection) Chen Chengxin (Shenzhen Institute of Metrology and Quality Inspection) Liang Bo (National Institute of Metrology) Long Siwei (Shenzhen Institute of Metrology and Quality Inspection) Participating drafters. Cao Yunfei (Wuhan Longcheng Measurement and Control Technology Co., Ltd.) Wang Xinyan (Shandong Metrology and Testing Center) Zhou Xinhua (Changsha Tianheng Measurement and Control Technology Co., Ltd.)

Table of contents

Introduction (Ⅱ) 1 Scope(1) 2 References(1) 3 terms(1) 4 Overview(1) 5 Metrological performance requirements (2) 5.1 Accuracy class and maximum allowable error(2) 5.2 DC input resistance(2) 5.3 Input Impedance(3) 5.4 Transmission impedance frequency response characteristics (3) 5.5 Preset alarm value error(3) 5.6 Indication error of test voltage (4) 6 General technical requirements (4) 6.1 Visual inspection (4) 6.2 Functional check (when applicable) (4) 7 Measuring Instrument Control(4) 7.1 Test conditions (4) 7.2 Verification items (5) 7.3 Verification method (6) 7.4 Processing of verification results (10) 7.5 Verification cycle (10) Appendix A Verification Original Record Format (11) Appendix B Format of the inner pages of the verification certificate/test result notification (page 2) (14) Appendix C Verification Certificate/Verification Result Notice Verification Result Page Sample (Page 3) (15) Appendix D Medical Leakage Current Measurement Device (19)

Introduction

JJF1002 "Rules for Writing National Metrology Verification Regulations", JJF1001 "General Metrology Terms and Definitions" and JJF1059.1 "Assessment and Expression of Measurement Uncertainty" together constitute the basic series supporting the formulation of this regulation specification. This regulation refers to GB 9706.1-2007 "Medical Electrical Equipment Part 1.General Safety Requirements" Contents of leakage current measuring devices involved. This regulation replaces the medical leakage current tester part of JJG 843-2007 "Leakage Current Tester". Compared with the part of JJG 843-2007 traditional Chinese medical leakage current tester, the main technical changes are as follows. --- Added terms and units of measurement; --- Increase the evaluation method of the leakage current measuring device; --- Modified the requirements for the maximum allowable error of the DC input resistance of the leakage current measuring device; --- Modified the content of JJG 843-2007 Appendix B, see Appendix D for details. The release status of previous versions of the regulations replaced by this regulation. ---JJG 843-2007; ---JJG 843-1993. Medical Leakage Current Tester

1 Scope

This regulation applies to the initial verification, subsequent verification and in-use inspection of medical leakage current testers.

2 References

This procedure references the following documents. GB 9706.1 Medical Electrical Equipment Part 1.General Safety Requirements IEC 80000-6.2008 Quantities and units Part 6.Electromagnetics (Quantitiesandunits-Part 6. For dated references, only the dated version applies to this regulation; for undated references document, its latest version (including all amendments) applies to this regulation.

3 terms

The following terms and definitions defined in GB 9706.1 apply to this regulation. 3.1 Measuring network measuring network A model circuit of the impedance of the human body and the response of the physiological effects of the human body composed of resistors and capacitors. Note. 1 See Appendix D for details of the measurement network circuit. 2 The output end of the measurement network is connected to a voltage measuring instrument, which should meet the requirements in GB 9706.1 Require. 3 The voltage measuring instrument connected to the measuring network and its output terminal shall be metered as a whole. In GB 9706.1, the measurement network and its The voltage measuring instrument connected to the output terminal is called a measuring device, abbreviated as MD (measuringdevice) in English. The current value indicated by the leakage current measuring device. The common logarithmic multiplication of the ratio of the modulus of the transmission impedance at each frequency of the measurement network to the modulus of the 10 Hz reference transmission impedance Take 20.

4 Overview

The medical leakage current tester (hereinafter referred to as the tester) is used in medical electrical equipment leakage current and patient auxiliary current Measurement. The tester is mainly composed of a medical leakage current measuring device (see Figure D.1) and an auxiliary test power supply connection circuit group become. Some of the testers have over-current protection and sound and light alarm setting functions. The schematic diagram of the working principle of the tester is shown in Figure 1.

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