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GB 9706.225-2021: Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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GB 9706.225-2021
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Basic data | Standard ID | GB 9706.225-2021 (GB9706.225-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | | Sector / Industry | National Standard | | Classification of Chinese Standard | C39 | | Word Count Estimation | 86,876 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 9706.225-2021: Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
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Medical electrical equipment -- Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
ICS 11:040:50
CCSC39
National Standards of People's Republic of China
Replacing GB 10793-2000
Medical electrical equipment part 2-25: electrocardiograph
Particular requirements for basic safety and basic performance
(IEC 60601-2-25:2011, MOD)
Published on 2021-12-01
2023-05-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Administration
directory
Preface III
Introduction VI
201:1 Scope, Purpose and Related Criteria1
201:2 Normative References 2
201:3 Terms and Definitions 2
201:4 General Requirements 4
201:5 General Requirements for ME EQUIPMENT Testing 4
201:6 Classification of ME EQUIPMENT and ME SYSTEM 5
201:7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENT 5
201:8 ME EQUIPMENT PROTECTION FROM ELECTRIC SHOCK HAZARD 8
201:9 Protection of me equipment and me systems against mechanical hazards 12
201:10 Protection against unwanted or excessive radiation hazards 12
201:11 Protection against ultra-temperature and other hazards 12
201:12 Accuracy of controllers and instruments and protection of hazardous outputs 12
201:13 Hazardous situations and fault states 25
201:14 Programmable Medical Electrical System (PEMS) 26
201:15 Structure of ME equipment 26
201:16 ME System 26
201:17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 26
202 Electromagnetic Compatibility --- Requirements and Tests 26
Addendum 32
Appendix AA (Informative) Specific Guidelines and Rationale 33
Appendix BB (Informative) Electrodes, Electrode Locations, Identification and Color Codes 38
Appendix CC (Informative) Leads, lead definitions and color codes (definitions other than:201:12:4:102) 40
Appendix DD (Informative) Polarity of patient leads (definitions other than:201:12:4:102) 41
Appendix EE (informative) Other electrode identification 42
Appendix FF (Informative) Definitions and Rules for Measurement of ECG Signals 43
Appendix GG (Informative) Databases for Calibration and Testing 48
Appendix HH (Informative) CTS Test Chart 50
Reference 79
Figure:201:101 Frank Lead System Electrode Position 6
Figure:201:102 Defibrillation protection (differential mode) (see:201:8:5:5:1) 10
Figure:201:103 Defibrillation protection (common mode mode) (see:201:8:5:5:1) 11
Figure:201:104 Applying a test voltage between lead wires to test the energy delivered by the defibrillator 12
Figure:201:105 Common Mode Rejection and Noise Level Test Circuit 17
Figure:201:106 General Test Circuit 19
Figure:201:107 Triangular wave 21 for Test E in Table:201:107
Figure:201:108 Input Pulse Signal and ECG Response 21
Figure:201:109 Circuit for linearity test 22
Figure:201:110 Results of Linearity Test 23
Figure:201:111 Pacemaker Overload Test Circuit 25
Figure 202:101 Radiated and conducted emission test setup 27
Figure 202:102 Radiated Immunity Test Setup 28
Figure 202:103 High-frequency surgical protective measures test circuit 30
Figure 202:104 High-frequency surgical protective measures test setup 31
Figure BB:1 Lead Colors and Electrode Locations in Fetal ECG Examination 39
Figure BB:2 Fetal scalp electrocardiogram lead locations and colors 39
Figure FF:1 Normal ECG 43
Figure FF:2 Determination of the complete interval (example) 44
Figure FF:3 Waveform Time Limit, Equipotential Section 45
Figure FF:4 QRS complex with small R waves46
Figure FF:5 Detailed illustration of what is identified as a small R wave 46
Figure FF:6 Detailed illustration of R-waves not recognized as small 47
Figure HH:1 Definition of terms for ECG signals for calibration 52
Figure HH:2 Definition of terms for ECG signals for analysis 54
Table:201:101 Basic performance requirements 4
Table:201:102 Electrodes and their location, identification and color codes5
Table:201:103 Defibrillation Protection (Test Conditions) 9
Table:201:104 Acceptance for time-limited measurements of complete intervals and Q-, R-, and S-waves using ECG data for calibration and analysis
mean and standard deviation of 13
Table:201:105 Acceptable mean errors and standard deviations for the overall duration and interval of the actual human ECG14
Table:201:106 Leads and their identification (name and definition) 15
Table:201:107 Frequency response 20
Table:201:108 Pacemaker Pulse Display Test Patient Electrode Connections 25
Table AA:1 Electrode location and electrical strength requirements 34
Table BB:1 Electrodes, electrode positions, markings and color codes (except for the definitions in:201:7:4:101 of Table:201:106) 38
Table BB:2 Electrode location, identification and color codes for other leads not covered by this document 38
Table DD:1 Electrode Polarity 41
Table EE:1 Recommendations for the use of 14-wire patient cable identification and color codes42
Table GG:1 ECG data for calibration and analysis 48
Table GG:2 Actual human ECG database used to test the accuracy of ECG measurements and waveform recognition - 100 copies selected
The ECG data obtained were from the International Common Criteria (CSE) database for quantitative electrocardiography, which was used on:201:12:1:101:3:2 49
Table HH:1 Nomenclature of Signals (ECG Signals for Calibration) 52
Table HH:2 Nomenclature of Signals (Analytical ECG Signals) 54
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents"
drafted:
This document is part 2-25 of GB 9706 "Medical Electrical Equipment": GB 9706 has released the following parts:
--- Part 1: General requirements for basic safety and basic performance;
--- Part 1-3: General Requirements for Basic Safety and Essential Performance Collateral Standard: Radiation Protection of Diagnostic X-ray Equipment;
--- Part 2-1: Specific requirements for basic safety and basic performance of electron accelerators with energies from 1MeV to 50MeV;
--- Part 2-2: Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;
--- Part 2-3: Specific requirements for basic safety and basic performance of shortwave therapy equipment;
--- Part 2-5: Specific requirements for the basic safety and basic performance of ultrasonic physiotherapy equipment;
--- Part 2-6: Specific requirements for basic safety and basic performance of microwave therapy equipment;
--- Part 2-8: Particular requirements for basic safety and basic performance of therapeutic X-ray equipment with energy from 10kV to 1MV;
--- Part 2-11: Particular requirements for basic safety and basic performance of gamma beam therapy equipment;
--- Part 2-12: Specific requirements for basic safety and basic performance of critical care ventilators;
--- Part 2-13: Particular requirements for basic safety and basic performance of anesthesia workstations;
--- Part 2-16: Particular requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;
--- Part 2-17: Special requirements for the basic safety and basic performance of automatically controlled brachytherapy afterloading equipment;
--- Part 2-18: Particular requirements for basic safety and basic performance of endoscopic equipment;
--- Part 2-19: Specific requirements for the basic safety and basic performance of infant incubators;
--- Part 2-24: Particular requirements for basic safety and basic performance of infusion pumps and infusion controllers;
--- Part 2-25: Particular requirements for basic safety and basic performance of electrocardiographs;
--- Part 2-26: Specific requirements for basic safety and basic performance of EEG machines;
--- Part 2-27: Particular requirements for basic safety and basic performance of ECG monitoring equipment;
--- Part 2-28: Particular requirements for basic safety and basic performance of medical diagnostic X-ray tube assemblies;
--- Part 2-29: Specific requirements for basic safety and basic performance of radiotherapy simulators;
--- Part 2-36: Particular requirements for the basic safety and basic performance of in vitro induced lithotripsy equipment;
--- Part 2-37: Particular requirements for basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;
--- Part 2-39: Particular requirements for basic safety and basic performance of peritoneal dialysis equipment;
--- Part 2-43: Particular requirements for basic safety and basic performance of interventional X-ray equipment;
--- Part 2-44: Particular requirements for the basic safety and basic performance of X-ray computed tomography equipment;
--- Part 2-45: Mammography equipment and mammography stereotaxic devices for basic safety and basic performance specific
Require;
--- Part 2-54: Particular requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;
--- Part 2-60: Particular requirements for basic safety and basic performance of dental equipment;
--- Part 2-63: Special requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging;
--- Part 2-65: Special requirements for basic safety and basic performance of intraoral imaging dental X-ray machines:
This document replaces GB 10793-2000 "Medical Electrical Equipment Part 2: Special Requirements for the Safety of Electrocardiographs": This document is related to
Compared with GB 10793-2000, in addition to structural adjustment and editorial changes, the main technical changes are as follows:
--- Integrate the content of YY0782-2010 into this document;
--- Modified the content of the term "gain" (see:201:3:210, 2:110 of the:2000 edition);
--- Modified the test method for defibrillation protection (see:201:8:5:5:1, 8:5:5:1 of the:2000 edition);
--- Added the term "Wilson Network Center Terminal" (see:201:3:201);
--- Added the term "channel" (see:201:3:202);
--- Added the term "DC bias voltage" (see:201:3:203);
--- Added the term "common mode rejection" (see:201:3:204);
--- Added the term "ECG report" (see:201:3:205);
--- Added the term "effective record width" (see:201:3:206);
--- Added the term "filter" (see:201:3:209);
--- Added the term "lead wire" (see:201:3:212);
--- Added the term "noise" (see:201:3:214);
--- Added the term "Wilson Network Center Terminal" (see:201:3:201);
--- Added general requirements (see:201:4);
--- Added supplementary requirements for basic performance (see:201:4:3);
--- Added other requirements for ME equipment testing (see:201:5:4);
--- Added the requirement that the protection against electric shock is a CF-type applied part (see:201:6:2);
--- Increased the classification of ME equipment and ME systems (see:201:6 except:201:6:6);
--- Increased identification, marking and documentation of ME equipment (see:201:7);
--- Added Programmable Medical Electrical System (PEMS) (see:201:14);
--- Added ME system (see:201:16);
--- Increased the electromagnetic compatibility of the ME system (see:201:17);
--- Increased electromagnetic compatibility - requirements and tests (see 202);
--- Delete the term "lead selector" (see 2:105 of the:2000 edition);
--- Delete the term "multi-channel electrocardiograph" (see 2:106 of the:2000 edition);
--- Delete the term "single-channel electrocardiograph" (see 2:111 of the:2000 edition);
--- Delete the term "calibration voltage" (see 2:112 of the:2000 edition);
--- Deleted the term "calibration" (see 2:113 of the:2000 edition):
This document uses the redrafted method to modify the use of IEC 60601-2-25:2011 "Medical Electrical Equipment Part 2-25: Electrocardiograph
Particular Requirements for Basic Safety and Essential Performance:
The technical differences between this document and IEC 60601-2-25:2011 and their reasons are as follows:
--- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment:
The situation is reflected in the:201:2 "Normative Reference Documents", and the specific adjustments are as follows:
● Replacing IEC 60601-1-2:2007 with YY9706:102-2021, which is an international standard;
● Replacing IEC 60601-2-2:2009 with GB 9706:202 which has been modified to adopt the international standard:
The following editorial changes have been made to this document:
---201:12:4:103 The order of switches in the third paragraph is incorrectly edited, and the first sentence of the third paragraph is modified to "open S5, close S1 and S2, and put S3
Place it in position B", and adjust the switch sequence before "applying a DC offset voltage of 300mV" to "disconnect S1 and place S3"
in position A";
---IEC original text editing error, "12 leads" in column 1 of Table:201:103 is changed to "10 leads";
--- The clause number "201:12:4:107:3" quoted in:201:12:1:108:3:1 is revised to "201:12:4:106:2";
--- Deleted the term index of the International Standard text:
Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed and managed by the State Drug Administration:
The previous versions of this document and its superseded documents are as follows:
--- First published in 1989 as GB 10793-1989, first revised in:2000;
---This is the second revision:
Introduction
Medical electrical equipment safety standards, also known as the 9706 series of standards, consist of general standards, side-by-side standards, specific standards, guidelines and interpretations:
--- General standard (GB 9706:1) is a safety standard that should be generally applicable to medical electrical equipment, that is, the equipment that meets the definition of medical electrical equipment:
All equipment should meet the requirements of this basic standard:
Only equipment with certain functions or characteristics needs to meet the requirements of such standards:
There are special standards for equipment:
In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows:
--- Part 2-4: Particular requirements for basic safety and basic performance of cardiac defibrillators: The aim is to establish the basics of a cardiac defibrillator
Specific requirements for safety and essential performance;
--- Part 2-22: Special requirements for the basic safety and basic performance of laser equipment for surgical, plastic, therapeutic and diagnostic use: the purpose is
Establish specific requirements for the basic safety and basic performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic use;
--- Part 2-66: Specific requirements for the basic safety and basic performance of hearing devices and hearing device systems: The purpose is to establish a listening
Particular requirements for basic safety and basic performance of force equipment and hearing equipment systems:
This document deals with specific requirements for basic safety and basic performance of ECG equipment: This document modifies and supplements GB 9706:1-2020
Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance:
This document contains YY0782-2010 "Medical Electrical Equipment Part 2-51: Recording and Analytical Single- and Multi-channel Electrocardiograph Safety
Full and Basic Performance Particular Requirements":
In this document, an asterisk (*) is used as the first character of a title or the beginning of a paragraph or table title, indicating that there is a reference to this item in Appendix AA:
Specific guidelines and principles related to the project are provided: The relevant content of Appendix AA will not only help to use this document correctly, but also add it in a timely manner:
Rapid process of revision of standards due to changes in clinical practice or technological developments:
Medical electrical equipment part 2-25: electrocardiograph
Particular requirements for basic safety and basic performance
201:1 Scope, Purpose and Related Standards
Except as described below, Chapter 1 of the General Standard applies:
201:1:1 *Scope
replace:
This document specifies the provision of diagnostic ECG reports by itself or as part of an ME system as defined in:201:3:63
The basic safety and basic performance of the electrocardiograph reported hereafter referred to as ME EQUIPMENT:
This document does not apply to the following situations:
a) the part of the ME EQUIPMENT that provides the ECG loop;
b) Holter electrocardiography ME equipment not used to obtain electrocardiographic reports for diagnostic purposes covered by YY9706:247;
c) ECG monitors that are not covered by GB 9706:227 for obtaining ECG reports for diagnostic purposes:
Note 1: ME equipment includes:
a) Direct-drawing electrocardiograph;
b) other ME equipment that provides electrocardiographic reports for diagnostic purposes, such as patient monitors, defibrillators and exercise testing devices;
c) away from the ECG machine that can still be displayed by the patient (for example, by telephone line, network or storage medium): These ME EQUIPMENT other than the transmission medium or
ME systems are within the scope of this document:
Note 2: ME equipment that provides diagnostic and monitoring function options shall meet the requirements of its corresponding standards when configuring functions:
ME equipment intended for use outside hospitals or clinics in extreme environmental conditions or in uncontrolled environments (e:g: ambulance, air transport)
equipment, should meet the requirements of this document: Additional standards apply to ME EQUIPMENT used in the above-mentioned environments:
201:1:2 Purpose
replace:
The purpose of this document is to establish specific requirements for basic safety and basic performance of electrocardiographs (see:201:3:63):
201:1:3 Tied standards
Added:
This document refers to Chapter 2 of the General Standard and the applicable collateral standards listed in:201:2 of this document:
YY9706:102 applies as amended by Chapter 202: GB 9706:103, YY9706:108 and YY/T 9706:110 are not applicable:
201:1:4 Particular standards
replace:
In the GB 9706 series, the special standard may modify, replace or delete the general standard and the parallel standard according to the special ME EQUIPMENT under consideration:
requirements contained in the standard: Other basic safety and basic performance requirements may be supplemented:
The requirements of the specific standard take precedence over the requirements of the general standard:
GB 9706:1-2020 is referred to as the general standard in this document: Collateral standards are indicated by their respective document numbers:
Chapter and article numbers in this document are prefixed with "201" to correspond to the general standard (e:g:,:201:1 in this document corresponds to section:201:1 of the general standard):
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