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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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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 9706.231-2023
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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Count Estimation | 45,439 | | Date of Issue | 2023-03-14 | | Date of Implementation | 2026-05-01 | | Older Standard (superseded by this standard) | YY 0945.2-2015 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the basic safety and basic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
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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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