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YY 9706.231-2023 English PDF

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YY 9706.231-2023: Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
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YY 9706.231-2023English859 Add to Cart 7 days [Need to translate] Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Valid YY 9706.231-2023

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Standard similar to YY 9706.231-2023

YY/T 1933   YY/T 1712   YY/T 1519   YY 9706.230   YY 9706.234   YY 9706.235   

Basic data

Standard ID YY 9706.231-2023 (YY9706.231-2023)
Description (Translated English) Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C39
Classification of International Standard 11.040.01
Word Count Estimation 45,439
Date of Issue 2023-03-14
Date of Implementation 2026-05-01
Older Standard (superseded by this standard) YY 0945.2-2015
Issuing agency(ies) State Drug Administration
Summary This standard specifies the basic safety and basic performance of external cardiac pacemakers powered by an internal power supply. This document applies to cables extending the distance between nonimplantable pulse generators and pacing lead wires, but not to cables enclosed with one or more insulated conductors, intended for use in external cardiac pacemakers and in patients' hearts Hoses that transmit electrical energy between them. This document does not apply to implanted parts of active implantable medical devices covered by GB 16174.1, external cardiac pacemakers that can be directly or indirectly connected to the power supply network, medical electrical equipment for transthoracic and esophageal pacing, and anticardiac Excessive speed of medical electrical equipment.

YY 9706.231-2023: Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source


---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.
ICS11:040:01 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0945:2-2015 Medical electrical equipment - Part 2-31: with interior Power supply for the basic safety of external cardiac pacemakers and Basic performance-specific requirements (IEC 60601-2-31:2020, MOD) 2023-03-14 release 2026-05-01 implementation Released by the State Drug Administration

table of contents

Preface III Introduction IV 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 testing of ME EQUIPMENT 5 201:6 Classification of me equipment and me systems5 201:7 Marking, marking and documentation of ME equipment 5 201:8 Protection against electric shock hazards for ME EQUIPMENT8 201:9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 13 201:10 Protection against unwanted or excessive radiation hazards (sources)13 201:11 Protection against extreme temperatures and other hazards (sources) 13 201:12 Accuracy of controls and instruments and protection against hazardous outputs13 201:13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 17 201:14 Programmable electrical medical systems (PEMS) 17 201:15 Construction of ME EQUIPMENT 17 201:16 ME system 18 201:17 Electromagnetic compatibility of me equipment and me systems18 202 * Electromagnetic Compatibility --- Requirements and Tests 18 Appendix 19 Appendix I Pass/Fail Criteria for Identifying Immunity 19 Appendix AA (Informative) Specific Guidelines and Rationale 20 Reference 37 Index of defined terms used in this document38 Figure:201:101 Test waveform V test 8 implemented using an example RCL circuit with C=120μF, L=25μH, RL R=1Ω Figure:201:102 Circuit Example of a Defibrillation Test Voltage Generator --- Can be used to generate a decaying exponential waveform 9 Figure:201:103 Test setup for a single-chamber external cardiac pacemaker 10 Figure:201:104 Test setup for a dual-chamber external cardiac pacemaker 10 Figure:201:105 Test setup for a three-chamber external cardiac pacemaker (for example: biventricular external cardiac pacemaker) 11 Figure:201:106 Timing 11 Figure:201:107 PATIENT AUXILIARY CURRENT MEASUREMENT CIRCUIT FOR ME EQUIPMENT (INCLUDING INTERNAL POWER SUPPLY) 12 Figure:201:108 Measurement circuit for maximum tracking frequency 15 Figure:201:109 Initial oscilloscope display when measuring the maximum tracking frequency 16 Figure AA:1 Simple model of a single-chamber external pacemaker during defibrillation 25 Figure AA:2 First recommendation on defibrillation protection testing of single-chamber external pacemakers27 Figure AA:3 Circuit for defibrillation test generator (defibrillation test according to the conditions during open heart surgery) 28 Figure AA:4 Defibrillation pulse generated by the defibrillation test generator of Figure AA:3 29 Figure AA:5 Rise time of a defibrillation pulse according to the circuit shown in Figure AA:333 Table:201:101 Basic Performance Requirements for Assignment 4 Table:201:102 Mark 5 of double lumen connector fittings Table:201:103 ME EQUIPMENT PARAMETERS 14 Table 202:101 Electrostatic discharge requirements 18 Table AA:1 External Pacemaker Hazard List 20 Table AA:2 Calculated pulse energy (C=120μF±5%) 30 Table AA:3 Calculated pulse energy (C=122μF±5%) 31 Table AA:4 Calculated pulse energy (C=126:32μF±5%) 32

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 for Standardization Documents" drafting: The "Medical Electrical Equipment" series of standards are divided into two parts: --- Part 1: General and parallel requirements; --- Part 2: Special requirements: This document is Part 2-31: This document replaces YY 0945:2-2015 "Medical Electrical Equipment - Part 2: Safety Special Purposes for External Pacemakers with Internal Power Supply" Require": Compared with YY 0945:2-2015, except for structural adjustment and editorial changes, the main technical changes of this document are as follows: --- Changed the defibrillation protection (see:201:8:5:5:1, 51:101 of the:2015 edition); ---Changed the measurement of patient auxiliary current (see:201:8:7:4:8, 19:4 of the:2015 edition); --- Increased the protection of high-frequency surgery ME equipment (see:201:8:101); --- Changed electrostatic discharge (see 202:6:2:2:1, 36:202:1 of the:2015 edition): This document is modified to adopt IEC 60601-2-31:2020 "Medical Electrical Equipment Part 2-31: External Cardiac Pacing with Internal Power Supply Basic Safety and Essential Performance Requirements for Devices": The technical differences between this document and IEC 60601-2-31:2020 and their reasons are as follows: --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments Centrally reflected in:201:2 "Normative Reference Documents", the specific adjustments are as follows: ● Replace IEC 60601-1:2005 AMD1:2012 with GB 9706:1-2020, which adopts the revised international standard; ● Replace IEC 60601-1-2:2014 with YY 9706:102-2021, which adopts the international standard: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on: The release status of previous versions of this document and the documents it replaces are as follows: ---First published as YY 0945:2-2015 in:2015; ---This is the first revision, and the file number is changed to YY 9706:231-2023:

Introduction

Safety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute: ---General standard: The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements: --- Parallel standards: safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards: ---Special standards: Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard: ---Guidelines and interpretations: application guidelines and explanations for the relevant requirements of the standards involved: The minimum safety requirements specified in this document are considered to provide a degree of safe practicality in the operation of external cardiac pacemakers: This document modifies and supplements GB 9706:1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance beg": Specifications for relevant tests follow the requirements: An asterisk (*) used as the first character of a title or the beginning of a paragraph or table title in this document indicates that there is a relevant item in Appendix AA: Project-specific guidelines and rationale: The relevant content in Appendix AA is not only helpful for the correct use of this document, but also for practical use: After changes in practice or technological development, the process of standard revision can be accelerated in a timely manner: However, Appendix AA is not a requirement of this document: part: Medical electrical equipment - Part 2-31: with interior Power supply for the basic safety of external cardiac pacemakers and Basic performance-specific requirements 201:1 Scope, purpose and relevant standards Except as described below, Chapter 1 of the general standard applies: 201:1:1 *Scope replace: This document specifies the basic safety and essential performance of external cardiac pacemakers powered by an internal power source: This document applies to cables extending the distance between non-implantable pulse generators and pacing lead wires, but not to cables enclosed with a or multiple insulated conductors, intended for use in hoses for the transmission of electrical energy between an external cardiac pacemaker and the patient's heart: Except for 7:2:13 and 8:4:1 of the general standard, the specific requirements in this document do not cover the expected Inherent danger to physiological function: NOTE: See 4:2 of the general standard: This document does not apply to the implanted part of active implantable medical devices covered by GB 16174:1: This document does not apply to direct External cardiac pacemakers connected directly or indirectly to the mains supply: This document does not apply to ME EQUIPMENT for transthoracic and esophageal pacing and ME EQUIPMENT for anti-tachycardia: 201:1:2 Purpose replace: The purpose of this document is to establish specific requirements for the basic safety and essential performance of external cardiac pacemakers as defined in:201:3:205: 201:1:3 Collateral Standards Supplement: This document refers to Chapter 2 of the General Standard and applicable collateral standards listed in:201:2 of this document: YY 9706:102-2021 is adopted in Chapter 202 according to the revised content: GB 9706:103 is not applicable: All in the 9706 series of standards Other published collateral standards apply: 201:1:4 Particular standards replace: In the 9706 series of standards, specific standards may modify, replace or delete general standards and collateral standards according to the specific me equipment under consideration: The requirements contained in the standard, and other basic safety and basic performance requirements may be supplemented: The requirements of a particular standard take precedence over the general standard: For the sake of brevity, this document refers to GB 9706:1-2020 as a general standard: Collateral standards are indicated by their respective document numbers: The numbers of chapters and clauses in this document correspond to the numbers of general standards by adding the prefix "201" (for example::201:1 in this document states Chapter 1 of the general standard), or correspond to the applicable collateral standard by adding the prefix "20×", where × is the document number of the collateral standard The last digit (for example: 202:6 of this document expounds the content of Chapter 6 of the collateral standard YY 9706:102):

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