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Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1874-2023: Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Status: Valid
Basic dataStandard ID: YY/T 1874-2023 (YY/T1874-2023)Description (Translated English): Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 128,146 Date of Issue: 2023-03-14 Date of Implementation: 2024-05-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies electromagnetic compatibility (EMC) tests for evaluating active implantable cardiovascular devices that can provide one or more treatments for bradycardia, tachycardia and cardiac resynchronization together with transvenous electrode lead systems method. This standard specifies performance limits for such devices when interacting with EM transmitters operating in the following two EM spectral ranges: 0 Hz �� f < 385 MHz; 385 MHz �� f �� 3000 MHz. This document also specifies the requirements for the protection of such devices from EM fields in medical environments, defines the required accompanying documentation, and provides information on EM emitter manufacturers and expected immunity levels. This document is intended for use with transvenous lead systems that provide one or more cardiac YY/T 1874-2023: Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices---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. ICS11:040:40 CCSC35 Pharmaceutical Industry Standard of the People's Republic of China YY/T 1874-2023/ISO 14117:2019 Electromagnetic Compatibility Test Rules for Active Implantable Medical Devices Implantable Cardiac Pacemakers, Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Devices (ISO 14117:2019, IDT) Released on 2023-03-14 2024-05-01 Implementation Released by the State Drug Administration table of contentsPreface V Introduction VI 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 3:1 Terms and Definitions 2 3:2 Symbols and abbreviations 3 4 0Hz≤f≤3000MHz frequency band test requirements 4 4:1 General requirements for all devices4 4:2 Electrode lead induced current 5 4:3 Protection against persistent faults caused by ambient electromagnetic fields 11 4:4 Protection against faults caused by short-term exposure to continuous wave sources 21 4:5 Protection against sensing electromagnetic interference as cardiac signals 24 4:6 Protection against static magnetic fields with flux densities up to 1 mT 32 4:7 Protection against static magnetic fields with flux densities up to 50 mT 33 4:8 Protection against AC magnetic field exposure in the frequency range 1 kHz to 140 kHz 34 4:9 Test requirements for 385MHz≤f≤3000MHz frequency range 35 4:10 Transient exposure to stationary low-frequency electromagnetic field sources in the frequency range 16:6 Hz to 167 kHz 38 5 Tests with frequencies higher than 3000 MHz 38 6 Protection of devices from electromagnetic fields in therapeutic environments 39 6:1 Protection of instruments against damage caused by high-frequency surgical exposure 39 6:2 Protection of devices from damage caused by external defibrillation 40 7 Other accompanying documents 43 7:1 Express permanent programmable sensitivity setting 43 7:2 Description of conversion modes 43 7:3 Known Potentially Dangerous Behavior 43 7:4 Minimum distance from handheld transmitters 44 Appendix A (Informative) Principle 45 A:1 Principles of test requirements for 0Hz≤f< 385MHz frequency band (see 4:1~4:8) 45 A:2 Principles of test requirements for 385MHz≤f≤3000MHz frequency band (see 4:9) 51 A:3 Principles of sample size 53 A:4 Principles of Chapter 6 Test Requirements 53 Appendix B (Informative) Principles of Test Frequency Range 55 APPENDIX C (INFORMATIVE) DESCRIBING CODES FOR IMPLANTABLE GENERATOR MODELS 56 C:1 Code 56 Appendix D (Normative) Interface Circuit 58 Appendix E (Informative) Selection of Capacitor Cx 63 Appendix F (Normative) Calibration of injection network (Figure D:5) 65 Appendix G (Normative) Torso Simulator 67 G:1 Torso Simulator 67 G:2 Top level grid 67 G:3 Cutout 67 G:4 Underlying grids 67 G:5 Torso simulator electrodes 67 G:6 Diagram 68 Appendix H (Normative) Dipole Antenna 70 H:1 Resonant dipoles 70 Appendix I (Normative) Pacemaker/ICD Program Control Settings 72 I:1 Overview 72 I:2 Pacemakers 72 I:3 ICD 73 I:4 Other operating modes or parameters not included in this document 74 Appendix J (Normative) Simulated Heart Signal 75 J:1 Cardiac analog signals 75 Appendix K (Normative) Calculation of Net Power of Dipole Antenna 76 K:1 Calculation of net dipole power 76 K:2 Measurement of the net power calculation factor 77 Appendix L (informative) loop area calculation 80 L:1 Purpose 80 L:2 Step 80 L:3 Results 81 L:4 Summary - Geometry Electrode Lead Loop Area 83 L:5 Effective sensing area 84 L:6 Lead Loop Area Considerations for CRT-P/CRT-D Devices and Left Ventricular Lead Placement 84 Appendix M (informative) Correlation between test voltage levels and radiated field strengths used in this document 85 Appendix N (informative) Connection with DUT with more than two electrode connection ports 91 N:1 Introduction 91 N:2 New nomenclature for ports and electrodes 91 N:3 Example of application of nomenclature in a typical DUT 92 N:4 Overview of organizing equivalent circuits and test setups 95 N:5 Multipole Common Mode Injection Configuration---Test 4:3/4:4/4:5 (to 10MHz) 99 N:6 Multipole Differential Mode Injection Configuration---Test 4:3/4:4/4:5 (up to 10MHz) 102 Appendix O (informative) Evaluation of transient and permanent CIED due to temporary exposure to low frequency (< 167kHz) electromagnetic fields Faulty Example Method 108 O:1 General considerations 108 O:2 Cardiac pacemakers and CRT-P devices 108 O:3 ICD and CRT-D devices 110 O:4 Principle of test signal modulation 111 References 113forewordThis document is drafted in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents": This document is equivalent to ISO 14117:2019 "Electromagnetic Compatibility of Active Implantable Medical Devices Implantable Cardiac Pacemakers, Implantable Electromagnetic Compatibility Test Rules for Cardioverter-Defibrillators and Cardiac Resynchronization Devices: 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 under the jurisdiction of the Active Implant Subcommittee (SAC/TC110/SC4) of the National Standardization Technical Committee on Surgical Implants and Orthopedic Devices: This document was drafted by: Shanghai Institute of Medical Device Inspection, Medtronic (Shanghai) Management Co:, Ltd:, Biotronic (Beijing) Medical Devices Machinery Co:, Ltd:, Chuangling Cardiac Rhythm Management Medical Devices (Shanghai) Co:, Ltd:, and Lepu Medical Electronic Instrument Co:, Ltd: The main drafters of this document: Wang Weiming, Li Qifei, Liu Jiawei, Zhang Botian, Qu Zehao, Qiu Fengwei, Jinhua:IntroductionThe number and number of electromagnetic (EM) emitters that patients implanted with active implantable cardiovascular devices were exposed to during their daily activities during the last 20 years Types have risen sharply: This trend is expected to continue: Due to the potentially life-sustaining nature of these devices, patients, industry and regulators The relationship between such transmitters and active implantable cardiovascular devices [pacemakers and implantable cardioverter-defibrillators (ICDs)] has been interaction between: The risks posed by this interaction include device inhibition or delivery of inappropriate therapy which, in the worst case, could lead to Serious injury or death of the patient: In recent years, other active implantable cardiovascular devices have emerged, not only pacemakers and ICDs, but also through Devices that optimize ventricular synchronization to improve cardiac output: Compared with pacemakers and ICD devices, although such devices can provide additional therapy, most of the EMC Requirements are similar, so in most cases the concepts that apply to pacemakers also apply to CRT-P devices, and for CRT-P Devices are tested in a manner similar to that for pacemakers: Similarly, concepts applicable to ICD devices are also The body applies to CRT-D devices, therefore, the method of testing CRT-D devices is similar to the method of testing ICD devices: Through standard test methods, the manufacturer can evaluate the electromagnetic compatibility performance of the product and prove that it can be used in the uncontrolled electromagnetic environment that the patient may encounter: environment, its products have an appropriate level of electromagnetic compatibility: It is important to make the manufacturers of emitters of electromagnetic fields and any other devices (intentional or not) aware that such devices may interfere with Normal operation of active implantable cardiovascular devices: It is important to understand that even if the device complies with the requirements of this document and the emitter complies with relevant human exposure safety standards and relevant regulatory emissions Requirements [eg: Federal Communications Commission (FCC) regulations], such interactions may also occur: Compliance with biosafety guidelines does not necessarily guarantee electromagnetic compatibility with active implantable cardiovascular devices: In some cases, for For such devices, the reasonably achievable electromagnetic immunity performance is lower than the limit value of such biological safety requirements: Please refer to Appendix M for the principle of applying ICNIRP1998 levels: The principles applicable to transmitters above 10 MHz can be found in Appendix M: The potential for a transmitter device to interfere with an active implantable cardiovascular device is complex and depends on the following factors: ---The frequency content of the transmitter, ---Modulation, ---signal power, ---Patient proximity, ---coupling coefficient, and --- Exposure duration: Transmitters with a fundamental carrier frequency not greater than 1 kHz have the potential to be sensed directly by cardiac pacemakers or ICDs: In addition, the heart A pacemaker or ICD can also sense a high-frequency carrier with a baseband modulation frequency below 500 Hz, at a sufficiently close range, and at a sufficiently high power: Additional details on this issue can be found in Appendix M: This document clarifies the electromagnetic compatibility of cardiac pacemakers and ICDs (not greater than 3000MHz), divided into several sub-terms: a) 0Hz≤f< 385MHz In the lower frequency bands (< 385MHz), there are many electromagnetic transmitters (eg: broadcast radio and television) and many new or existing New applications of technology may increase the probability of interaction between the transmitter and the patient's pacemaker and ICD: Examples are as follows: ---Electronic Article Surveillance (EAS) system; ---Access control system (radio frequency identification or RFID); --- New wireless services in UHF and VHF bands; ---Maglev track system; --- Radio frequency (RF) medical operations (such as high frequency surgery and ablation therapy); ---metal detector; ---Magnetic resonance imaging; --- Experimental use of transponders for traffic control; ---Wireless charging system for electric or hybrid vehicles: b) 385MHz≤f < 3000MHz Such frequencies f are typically those of personal handheld communication devices such as cordless telephones and two-way radios: Twenty years ago, patients with pacemaker implants who used hand-held transmitters or were exposed to electromagnetic fields from portable transmitters were relatively uncommon: Fewer, mostly handheld FM transceivers for commercial, public safety, and amateur radio communications: However, in the last 15 years, the ring The environment has changed rapidly: As the technology matures and becomes widely accepted by the public, wireless telephone systems are becoming more and more common: therefore, Many groups of pacemaker and ICD patients are exposed to electromagnetic fields from their own or others' portable radiotelephone transmitters increasingly likely: In addition, new applications of microwave frequencies can be expected to increase as the wireless technology revolution progresses: Most electronic equipment, including external medical devices, is designed to be compatible with relatively low-level electromagnetic conditions: out of Aware of the various electromagnetic environments a patient may encounter, implantable devices are designed to operate at higher Electromagnetic compatibility is achieved under the amplitude condition: In some cases, however, even increased noise immunity may not be sufficient to match implantable Compatibility of complex electric and magnetic fields generated by low power transmitters within a few centimeters of the device: Research in the mid-1990s indicates that some models of pacemakers and ICDs are not sufficiently immune to operate in close proximity to certain hand-held transmitters (eg, radio phone and two-way radio) for unrestricted use: Although operating limitations help avoid problems with implantable Electromagnetic interaction, but this approach is not the best long-term solution: In contrast, the preferred method is to improve electromagnetic compatibility, Meet patient expectations for wireless service with minimal operational constraints: Technological developments have led to an ever-expanding range of transmitters to which patients may be exposed to electromagnetic hazards: --- small radiotelephone; ---Introduction of digital technology; --- Peak transmitter power: Today's wireless phones are so small that patients can place the phone in communication or in standby mode implanted against the chest in the instrument pocket: Based on various wireless telephony standards, a range of power levels and modulation schemes can be developed: Most digital wireless phones are capable of producing produce higher peak transmit power than analog phones: Such factors lead to a greater potential interaction with pacemakers and ICDs: For the frequency of 385MHz≤f≤3000MHz, this document clearly stipulates that the dipole antenna should be carried out under the net power of 120mW Wire test to simulate a handheld wireless transmitter at a distance of 15 cm from the implant: Higher power levels can also be used to simulate placement in A hand-held wireless transmitter closer to the implant is used to characterize the test: c) f≥3000MHz This document does not require testing of devices above 3 GHz: The frequency caps chosen for this document reflect consideration of the following factors: Factor considerations: ---Radiator types for frequencies above 3GHz; --- At microwave frequencies, the device protection provided by the shell and body tissue attenuation increases; --- The expected performance of the EMI control function generally meets the low frequency requirements of this document; and --- Under microwave frequency conditions, the sensitivity of the circuit is reduced: See Chapter 5 for more details: In conclusion, it is reasonably foreseeable that patients using cardiac pacemakers and ICDs will be exposed to an increasingly complex electromagnetic environment: In addition, new technology Rapid changes in surgery and patient acceptance of new technologies will lead to increasing expectations for unrestricted use: based on the ever-changing The electromagnetic environment and customer expectations, manufacturers will need to evaluate their product designs to assess the complex fields, broad Frequency range and compatibility with various modulation schemes: Appendix A provides a rationale for certain terms of this document in order to provide useful background information for reviewing, applying and revising this document: This rationale is intended for persons familiar with the subject matter of this document, but who were not involved in its drafting: Notes in this appendix apply to relevant clauses, sub- Clauses or appendices, therefore, may not be numbered consecutively: Electromagnetic compatibility of active implantable medical devices Implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Compatibility testing rules1 ScopeThis document specifies procedures for the evaluation of one or more of the bradycardia, tachycardia, and cardiac Electromagnetic compatibility (EMC) test methods for active implantable cardiovascular devices for resynchronization and other treatments: NOTE: This document is designed for pulse generators used with endocardial leads or epicardial leads: For those who do not use endocardial or epicardial electrocardiography Pulse generators using polar lead technology, adjusted at the discretion of the manufacturer using these technologies: This document specifies performance limits for such devices when interacting with EM transmitters that may operate in the following two EM spectral ranges: ---0Hz≤f< 385MHz; ---385MHz≤f≤3000MHz: This document also specifies the requirements for the protection of such devices from EM fields in medical environments, defines the required accompanying documents, and provides information about EM transmitter manufacturers and expected immunity levels: This document applies to transvenous lead systems that can provide one or more of bradycardia, tachycardia, and cardiac resynchronization, etc: Therapeutic Active Implantable Cardiovascular Devices:2 Normative referencesThe contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references, Only the version corresponding to the date applies to this document; for undated references, the latest version (including all amendments) applies to this document: ISO 14708-1:2014 Surgical implants Active implantable medical devices Part 1: General requirements for safety, marking and information provided by the manufacturer Note: GB 16174:1-2015 Surgical implants Active implantable medical devices Part 1: General requirements for safety, marking and information provided by the manufacturer (ISO 4708-1:2000, IDT) ISO 14708-2:2019 Surgical implants Active implantable medical devices Part 2: Cardiac pacemakers Note: GB 16174:2-2015 Surgical Implants Active Implantable Medical Devices Part 2: Cardiac Pacemakers (ISO 14708-2:2005, IDT) ISO 14708-6:2019 Surgical implants Active implantable medical devices Part 6: Active devices for the treatment of tachyarrhythmias Note: YY 0989:6-2016 Active implantable medical devices for surgical implants Part 6: Active implantable medical devices for the treatment of tachyarrhythmias (including implantable defibrillators) specific requirements (ISO 14708-6:2010, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1874-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 1874-2023_English as soon as possible, and keep you informed of the progress. 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