YY 0782-2010 English PDF
Basic dataStandard ID: YY 0782-2010 (YY0782-2010)Description (Translated English): Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C39 Classification of International Standard: 11.040.60 Word Count Estimation: 77,742 Date of Issue: 2010-12-27 Date of Implementation: 2012-06-01 Adopted Standard: IEC 60601-2-51-2003, IDT Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97 Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the type of recording and analyzing single channel and multi-channel ECG machine safety requirements and basic performance requirements. Single-channel and multi-channel ECG machine has been carried out in 2. 101, 2. 111, 2. 117, 2. 123, 2. 126 defined, hereinafter referred to as devices. Such equipment may not be left unattended or unsupervised. The specific standard complements GB 10793-2000. YY 0782-2010: Medical electrical equipment. Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs---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. Medical electrical equipment.Part 2-51. Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel of electrocardiographs ICS 11.040.60 C39 People's Republic of China pharmaceutical industry standards YY 0782-2010/IEC 60601-2-51.2003 Medical electrical equipment - Part 2-51. Recording and analysis of single and multi-channel ECG machine safety And essential performance Part 2-51. Particularrequirementsforsafety, includingessentialperformance, (IEC 60601-2-51.2003, IDT) Issued on. 2012-06-01 2010-12-27 implementation State Food and Drug Administration issued Table of ContentsPreface Ⅳ Introduction Ⅴ The first chapter outlines 1 Scope and purpose 1 1.1 * Range 1 1.2 Objective 1 1.3 Specific Standard 1 2 Terms and definitions 2 4 4 General test requirements 6 Identification, marking and documents 5 The second environmental conditions Third of the risk of electric shock protection Title IV of the mechanical hazards Protection The fifth chapter of unwanted or excessive radiation hazard protection Title VI of flammable anesthetic mixture ignition risk protection Title VII of the over-temperature and other security risk protection Protection accuracy and dangerous work output data of the eighth chapter 7 50 Operating data accuracy 51 protection dangerous output 14 Chapter 9. abnormal operation and fault conditions; Environmental Testing Tenth Canto structural requirements 56 26 components and subassemblies Annex L (normative) --- standard reference publications mentioned in 32 Annex AA (informative) Theoretical and General Guidelines 33 Appendix BB (informative) electrode, the electrode position, definition and color code 39 YY 0782-2010/IEC 60601-2-51.2003 Annex CC (informative) leads the definition of leads (Definitions In addition to the 51.101) 41 Appendix DD (informative) polarity of patient leads (Definitions In addition to the 51.101) 43 Other electrode identification Appendix EE (informative) 44 Appendix FF (normative) Noise 46 Appendix GG (normative) definitions and rules ECG 48 Appendix HH (normative) Calibration and testing database 54 Appendix II (Information Appendix) CTS test pattern 57 References 67 Index 68 101 According to Frank electrode position (see Table 101) 27 102 patients polar leads (see 51.101.1) 27 103 Weighted network and input impedance of the test pattern (see 51.101.2.2 and 51.102.1) 27 Figure 104 CMR test (see 51.105.1 and 51.106.4) 28 105 Table 114 Test E triangular wave (see 51.107.1.1.1) 29 106 input pulse signal (dashed line) and ECG response (solid line) (see 51.107.1.1.2) 29 Linearity test circuit 107 (see 51.107.2) 30 Linearity test results in Fig. 108 (see 51.107.2) 30 109 test results rectangle coordinates (see. 51.108.4.1) 31 Figure BB.1a) leads with color fetal ECG (see 6.1, table BB.1) 40 Figure BB.1b) Fetal Fetal ECG electrode positions (6.1, Table BB.1) 40 Figure BB.2 fetal scalp ECG lead position and color (see 6.1, table BB.1) 40 Figure CC.1 Frank lead system network 42 Figure EE.1 Code 1 correspondence between the electrodes and the color 44 Figure FF.1 patients with ECG machine is connected to the analog circuit 46 Figure FF.2 typical ECG input circuit configuration and equivalent circuit 47 FIG GG.1 normal ECG 48 FIG. 49 is determined GG.2 whole period between Figure GG.3 time waveform, and other potential section 50 Figure GG.4 acceptable small R wave of the QRS complex 52 Figure GG.5 small R wave unacceptable QRS complex 52 Figure GG.6 was identified as a detailed illustration of small R wave 53 Figure GG.7 not be recognized as a detailed illustration of small R wave 53 Figure II.1 CTS test system 58 Example Figure II.2 signal conditioning circuit 59 Figure II.3 calibration term ECG signals by naming 61 ECG signal with the terms defined analysis 64 Figure II.4 Figure II.5 noise 65 Table 101 electrode and neutral electrode location, logo and color code 6 Table 102 data through a 3.2s time constant of a first-order high-pass filter, the ST segment and T wave generated by the bias voltage Amplitude reference value 8 YY 0782-2010/IEC 60601-2-51.2003 Table 103 using the calibration and analysis between the overall time period and Q, R and S-wave measurement of ECG data acceptable The mean and standard deviation of 9 Table 104 using the actual body overall ECG interval measurements and time frames acceptable average error and standard deviation of 9 The change in the measurement result table 105 ECG caused by noise announcement (using Table HH.3 listed electrocardiogram data) 10 Table 11 lists the results of the test 106 Table 107 publicly explain the format of the diagnostic accuracy of 12 Table 108 discloses rhythm diagnostic accuracy 13 format Electrode connection table 109 of a particular lead 14 Table 110 leads its identification (name and definition) 14 Table 111 Goldberger and Wilson lead network 16 Table 112 Frank (Frank) network leads 17 Table 113 Input impedance - Lead selector position, the case of connecting the lead electrode and the opening of the output waveform S1 Peak - valley amplitude 18 Table 114 Frequency response 22 Table BB.1 electrode, the electrode position, definition and color code (see further description of 6.1, table 101) 39 Table 43 DD.1 electrode polarity Table EE.1 14 wire patient cable color code identifies 45 recommendations Table HH.1 calibration and analysis of ECG data 54 The actual human electrocardiogram table HH.2 for testing ECG measurements and waveform recognition accuracy database 55 Test Data Sheet HH.3 stability with anti-noise 56 Table II.1 named signal (ECG signal calibration) 62 Table name II.2 signal (ECG signal analysis) 64 YY 0782-2010/IEC 60601-2-51.2003ForewordMedical electrical equipment standard series of standards, the series standard consists of two parts. --- Part 1. General requirements for safety of medical electrical equipment; --- Part 2. Medical electrical equipment requirements for the safety. This special standard - Part 2-51 Medical electrical equipment. The specific standard is based on GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety "(hereinafter. General Standard) of the specific standards, it is GB 9706.1 of changes and additions, And supporting the use of GB 9706.1. The use of specific standard translation method identical with IEC 60601-2-51.2003 "Medical electrical equipment - Part 2-51. recording and analysis Single and multi-channel ECG machine safety and essential performance. " The specific standard IEC 60601-2-51.2003 made the following editorial changes. --- Other international standards quoted in the standard, if it has the appropriate standards into our country, places of reference standards prevail; --- Remove IEC 60601-2-51.2003 cover and foreword, according to GB/T 1.1 standards require rewriting; The specific standard of medical equipment by the National Standardization Technical Committee of Standardization Technical Committee of Medical Appliances (SAC/TC10 / SC5) centralized. The specific standard drafting unit. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen Edan Precision Instrument Co., Ltd., Shanghai Medical Spa instrument detection. The main drafters of this specific standard. Ye Wenyu Xie Xicheng, Shiwen Li, Ye Jilun. YY 0782-2010/IEC 60601-2-51.2003IntroductionThis standard relates to special additional safety records and analysis of single and multi-channel ECG device. It changes and additions The GB 9706.1-2007, hereinafter referred to as the universal standard version. The specific requirements of the standard in preference to "Medical Electrical Equipment Part 1 Score. General Requirements for Safety "common standards. For the "general guidelines and basic principles," the special requirements of this standard in Annex AA. Standard text in front of the reg number raises a "*" indicates that provision in Annex AA further explanation and clarification. We believe that these requirements will not only help to understand the proper use of this standard, and in time to accelerate due to changes in clinical practice or Technological development and to accelerate the standard revision process. However, this is not a standard part of the Appendix of this requirement. YY 0782-2010/IEC 60601-2-51.2003 Medical electrical equipment - Part 2-51. Recording and analysis of single and multi-channel ECG machine safety And essential performance The first chapter outlines In addition to the following, the common standards Benpian apply.1 Scope and purposeIn addition to the following, the common standards in this chapter apply. 1.1 * Range Addition. This standard specifies the special safety requirements for recording and analyzing single channel and multi-channel ECG machine and the basic performance requirements. Single-channel and multi-channel heart FIG electric machine has been defined in the 2.101,2.111,2.117,2.123,2.126, hereinafter referred to as devices. Such equipment may have been Custody or unattended. This special supplement standard GB 10793-2000. 1.2 Purpose Alternative. In addition to GB 10793-2000 in terms of security made some additional requirements beyond the specific purpose of the standard is to establish a close For recording and analyzing single channel and multi-channel ECG machine safety and essential performance of special requirements. The only requirements for particular application. --- Type recording ECG; --- ECG machine, ECG machine that is part of one of the other medical electrical equipment, such as exercise test system, if the ECG FIG machine is used to record the ECG and for diagnostic purposes; --- ECG is used as the database management system of the output unit of the ECG machine, or place in the absence of a recording device as an output ECG unit; --- Analytical ECG machines, systems and computing equipment, which by electrocardiogram electronic data processing and pattern recognition approach Measurement (such as intervals and amplitudes) and diagnostic instructions; --- Having realized analytical analysis of patient ECG monitor ECG or other special part of ECG machine. This standard does not apply to Holter ECG, invasive ECG, patient monitoring systems, and other high-resolution other than the above ECG (electrocardiogram machine such as HIS bundle with late potential detection of ECG). 1.3 Specific Standard Addition. The specific reference standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" and GB 10793-2000 "Medical electrical equipment - Part 2-25. ECG requirements for the safety." YY 0782-2010/IEC 60601-2-51.2003 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0782-2010_English be delivered?Answer: Upon your order, we will start to translate YY 0782-2010_English as soon as possible, and keep you informed of the progress. The lead time is typically 5 ~ 8 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY 0782-2010_English with my colleagues?Answer: Yes. The purchased PDF of YY 0782-2010_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
