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GB 9706.8-2009 English PDF

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GB 9706.8-2009: Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators
Status: Obsolete

GB 9706.8: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 9706.8-2009	English	1759	Add to Cart	5 days [Need to translate]	Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators	Obsolete	GB 9706.8-2009
GB 9706.8-1995	English	959	Add to Cart	4 days [Need to translate]	Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors	Obsolete	GB 9706.8-1995

PDF similar to GB 9706.8-2009

Standard similar to GB 9706.8-2009

YY/T 1933 YY/T 1712 GB 9706.227 GB 9706.204 GB 9706.222 GB 9706.255

Basic data

Standard ID	GB 9706.8-2009 (GB9706.8-2009)
Description (Translated English)	Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators
Sector / Industry	National Standard
Classification of Chinese Standard	C39
Classification of International Standard	11.040.10
Word Count Estimation	44,472
Date of Issue	2009-05-06
Date of Implementation	2010-03-01
Older Standard (superseded by this standard)	GB 9706.8-1995
Adopted Standard	IEC 60601-2-4-2002, IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 4, 2009 (No. 144 overall)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This Chinese standard specifies specific safety requirements for cardiac defibrillators, cardiac defibrillators hereinafter referred to herein as a device. This standard does not apply to special implantable defibrillators, remote defibrillator, in vitro percutaneous pacemaker, separate single- established heart monitor (meet GB 9706. 25). Use separate ECG electrodes heart monitor is not within the scope of this standard, unless it is as an automatic external defibrillator (AED) or synchronous cardiac rhythm recognition and detection of cardiac electrical cardioversion sole basis using detection. Defibrillation waveform technology is developing rapidly. Literature studies show the effectiveness of the different waveforms. The scope of this standard specifically excludes special waveform selection, which includes the waveform shape, release energy, efficacy and safety. However, the importance of the waveform due to the treatment is critical, so the principle that adds a note explaining how to assess the waveform selection.

GB 9706.8-2009: Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators

---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 2-4. Particular requirements for the safety of cardiac defibrillators ICS 11.040.10 C39 National Standards of People's Republic of China GB 9706.8-2009/IEC 60601-2-4.2002 Replacing GB 9706.8-1995 Medical electrical equipment - Part 2-4. Requirements for the safety of cardiac defibrillators (IEC 60601-2-4.2002, IDT) Published 2009-05-06 2010-03-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China issued

Introduction Ⅲ The first chapter outlines 1 And a range of object 1 2 Terms and Definitions 2 General claim 3 Test 4 5 Category 4 6 to identify, mark and file 4 The second environmental conditions 7 10 environmental conditions 7 Title III of the danger of electric shock protection 7 Requirements related to the classification of 14 8 17 isolation 8 19 Continuous leakage currents and patient auxiliary current 9 Dielectric strength 20 9 Title IV of protection against mechanical hazards 11 The fifth chapter of unnecessary or excessive radiation hazard protection 11 36 electromagnetic compatibility (EMC) 11 Title VI protection 13 pairs mixed flammable anesthetic gas ignition hazard Title VII of the ultra-mild other security risk protection 13 42 overtemperature 13 Overflow 44, liquid spill, leak, moisture, into the liquid, cleaning, disinfection, sterilization and compatibility 13 46 14 human error 14 accuracy and prevent the risk of data output from the eighth chapter of the work Accuracy of operating data 14 50 Prevent danger output 1551 Chapter 9. abnormal operating and fault states; Environmental Testing 15 52 failure and abnormal operation state 15 Tenth chapter 15 structural requirements Component assembly 15 and 56 Mains supply portion 57, and the wiring 16 Component Article one and supplement the relevant safety requirements 17 Charging time 17 101 Internal power supply 102 19 103 persistence 20 104 synchronizer 21 Monitor/ECG input 21 of the defibrillation recovery 105 106 inside the discharge or charge interference monitor 21 101 limits energy between different parts of the test device and the defibrillator electrode [see Chapter 17 aa)] 22 GB 9706.8-2009/IEC 60601-2-4.2002 FIG test device 102 and a flexible cord fixing apparatus [see 56.101 in b) Test 2] 23 FIG defibrillation recovery test apparatus 103 (see 105.1) 23 FIG monitoring electrodes 104 disposed on the sponge (see 105.2) 24 FIG defibrillation recovery test apparatus 105 (see 105.2) 24 FIG interfering test device 106 charging and discharging the interior (see Chapter 106) 25 Example 26 Soft wire fixture 107 needs to be tested Annex L (normative) Normative References 27 Annex AA (informative) General guidelines and principles Note 28 Annex BB (informative) AEDs. Background and Rationale 35 GB 9706.8-2009/IEC 60601-2-4.2002

Foreword

All technical contents of this specific standard is mandatory. Medical electrical equipment standards for the standard series, the series of standards consists of two major components. --- Part 1. General requirements for medical electrical equipment; --- Part 2. Safety requirements for medical electrical equipment. This is a specific standard for medical electrical equipment in Part 2. Particular requirements for safety of cardiac defibrillators. This specific standard and GB 9706.1- 2007 "Medical Electrical Equipment Part 1. General requirements for safety" supporting the use together. This specific standard equivalent to the International Electrotechnical Commission IEC 60601-2-4.2002 "Medical electrical equipment - Part 2-4. cardiac defibrillators Requirements for the safety. " To IEC 60601-2-4.2002, this specific standard made the following editorial changes. --- removed IEC 60601-2-4.2002 standard cover, foreword and introduction; --- For the standard international standards referenced, if China has been transposed into national standards, then changed to refer to our standards; --- to IEC 60601-2-4.2002 standard terms in capital letters, this standard are marked in boldface. Instead of this specific standard GB 9706.8-1995 "Medical Electrical Equipment Part II. cardiac defibrillators and monitors cardiac defibrillator Special security requirements. " This main differences compared to the specific standard GB 9706.8-1995 follows. --- increased demands on the automatic external defibrillator; --- increasing the electromagnetic compatibility requirements. Date on which the specific standard and shall replace abolished GB 9706.8-1995. Annex L of this specific standard specification appendix, Appendix AA, BB Appendix informative appendices. This specific standard proposed by the State Food and Drug Administration. This specific standard by the National Standardization Technical Committee of Medical Electrical Medical Electronic Instrument Standardization Technical Committee. This specific standard drafting units. Shanghai Medical Device detection, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The main drafters of this specific standard. Yu and Zhou match the new. This special standard supersedes the previous editions are. --- GB 9706.8-1995. GB 9706.8-2009/IEC 60601-2-4.2002 Medical electrical equipment - Part 2-4. Requirements for the safety of cardiac defibrillators The first chapter outlines Except as follows, common standards applicable Benpian.

1 Scope and purpose

Except as follows, common standards applicable in this chapter. 1.1 range Supplement. This standard specifies the special safety requirements defined in 2.1.101 cardiac defibrillator, hereinafter referred to herein as a cardiac defibrillator device. This does not apply to specific standard implantable defibrillators, remote defibrillators, pacemakers vitro transdermal, a separate stand-alone heart monitor (in accordance with GB 9706.25). The use of a separate ECG heart monitor electrodes scope of this standard is not, unless it is automatically as the body The only reference heartbeat detected external defibrillator (AED) or synchronous rhythm identification detection Cardioversion use. Defibrillation waveform technology is developing rapidly. Literature studies have shown the effectiveness of different waveforms. The scope of the present standard does not specifically include special Selected waveform, comprising a waveform shape, the release of energy, safety and efficacy. However, due to the importance of wave treatment it is critical, so the principle explanation added comments to explain how to consider the waveform select. 1.2 Purpose replace. Purpose of this standard is to establish specific requirements for the safety 2.1.101 defined in cardiac defibrillator. 1.3 Specific Standard Supplement. This specific standard reference GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." Referred to in Part 1 of this specific standard as "General Standard" or "General requirements." This specific standard for each chapter, the chapter and section numbers are corresponding to the general standard, the standard provisions for changes in general represented by the following terms. "Replace" represents a standard general chapter or completely replaced by the terms of this specific standard provisions. "Added" means the provisions of the specific standard for common standards is required to increase. "Modify" means according to the provisions of this standard is dedicated to the General Standard or modify the terms of Chapter. To increase the general standard terms or drawing numbered starting from 101, additional annexes are lettered as AA, BB, etc., increased project As aa), bb) and so on. The term "present standard" is used to refer to this specific standard common standards and collectively. When the universal standard articles, Chapter terms (irrelevant if not impossible) without corresponding articles, chapters and clauses in this specific standard, no more Change applies. When any part of a universal reference standard is not expected (even possibly related), this does not apply to given specific standard Chen Shu. This standard requires special preference to the respective requirements of common standards. 1.5 Collateral Standard Supplement. The following standards apply in parallel. GB 9706.15-2008 Medical Electrical Equipment Part 1-1. General requirements for safety Collateral Standard. safety to medical electrical systems GB 9706.8-2009/IEC 60601-2-4.2002 Find (IEC 60601-1-1.2000, IDT) YY0505-2005 Medical Electrical Equipment Part 1-2. General requirements for safety Collateral Standard. EMC requirements and tests (IEC 60601-1-2.2001, IDT) IEC 60601-1-4.1996 Medical Electrical Equipment Part 1-4. General requirements for safety Collateral Standard. Programmable Electrical Medical system

2 Terms and Definitions

Except as follows, common standards applicable in this chapter. Added definitions. 2.1.101 Electric pulses applied through the electrode in the heart (the electrode body) the patient's skin (in vitro electrode) or exposed for cardiac defibrillation Medical electrical equipment. You can call or defibrillator device. Note. This device may also include other care or treatment function. 2.1.102 It is part of the defibrillator, which provides a visual display of the patient's heart activity. NOTE. This term in this specific standard is used to distinguish and monitor a separate device, even if the device is a separate stand-alone monitor, it provides to defibrillator Synchronizing signal as a reference detection rhythm recognition or automatic external defibrillator provides control signals to the defibrillator. 2.1.103 Means for charging the defibrillator to the energy storage circuit. The circuit comprises at the time of charging the energy storage device electrically connected with a Some. 2.1.104 As a release electrical pulses to the patient in order to achieve the purpose of cardiac defibrillation electrodes. Note. The defibrillator may also provide other monitoring electrodes (e.g., ECG acquisition) or treatment (e.g., percutaneous pacing) function, and it may be disposable or repeated in use. 2.1.105 Circuit means connected to the energy reservoir defibrillator within the defibrillator electrodes. The switching circuit includes all between the device and the defibrillator electrode connection. 2.1.106 Including a manually operated discharge control circuit portion and all electrical connections thereto. 2.1.107 Without passing through the defibrillator electrodes defibrillator discharge circuit of the energy storage device. 2.1.108 Cardiac defibrillator so that particular cycle phase-synchronized with the discharge means. 2.1.109 Once activated by the operator, by placing the analyzed electrocardiogram (ECG) obtained in the chest body surface electrodes, to identify a shockable cardiac rhythm when GB 9706.8-2009/IEC 60601-2-4.2002 Can be detected during operation of the defibrillator self-shockable rhythm, hereinafter referred to as AED. Note. AED can provide different levels of automation, they have different titles. See Appendix BB. 2.1.110 Member to be charged (e.g., a capacitor) electrical defibrillation pulse to the patient to release the necessary energy. 2.1.111 Electrodes applied to a patient for the purpose of monitoring the patient. These electrodes do not have to release the defibrillation pulse to the patient. 2.1.112 ECG analysis and identify whether a shockable heart rhythm system. In its AED algorithm is designed for the clinical It detects abnormal heart rhythm requires defibrillation shock, its sensitivity and specificity. It may be referred to RRD. 2.12.101 Released by the defibrillator electrode, and a predetermined energy dissipation in the patient or in the resistance of the resistor. 2.12.102 The device is operating device is not charging the energy storage mode of operation. 2.12.103 Defibrillator energy stored in the energy storage device. 2.12.104 Alternatives for testing analog transformers, and other molded semiconductor device. Fictitious test device will be equal in alternative geometrically Pieces. Direct local performance is not the original volume of the molding member (semiconductor silicon wafer, the transformer core and windings). Substitute member is not more than A case where the internal voltage maximum fictional device with the correct geometry such that creepage test, and the dielectric strength of the gap becomes possible. 2.12.105 When generating an analog electrical output to a cardiac defibrillator, cardiac defibrillator capable of measuring the output energy of the instrument. 2.12.106 Determined by manual setting or automatic treatment protocol (protocol) defibrillator expected energy release. 2.12.107 Used to describe a defibrillator designed for guaranteed term of more than 2,500 discharges (see Chapter 103). 2.12.108 Used to describe a defibrillator designed for guaranteed term of less than 2500 discharges (see Chapter 103). 2.12.109 Energy can be selected manually by the operator, the charging and discharging of the defibrillator. General requirements Test 4 Except as follows, common standards applicable in this chapter. GB 9706.8-2009/IEC 60601-2-4.2002 4.5 ambient temperature, humidity, atmospheric pressure Supplement. aa) 102.2 and 102.3 in the test should be performed at the required temperature conditions ± 0 ℃ 2 ℃. 4.6 Other conditions Added items. aa) Unless otherwise specified in this standard, all tests for all types of defibrillators (manual, AED, frequent and infrequent use Use defibrillator). 4.11 Test procedure Supplement. Persistent Test Chapter 103 requirements shall be in over-temperature test (see Chapter General Standard C20) after. Chapter 101, Chapter 102, Chapter 104, Chapter 105 test requirements and Chapter 106, Appendix C should in general C35 Standard Cap After the test. 5 classification Except as follows, common standards applicable in this chapter. 5.2 Classification according to the degree of protection against electric shock modify. Delete Application Part B type. 6 to identify, mark and file Except as follows, common standards applicable in this chapter. External marking device or apparatus components 6.1 j)  input power Alternatively (in the opening paragraph is "If the device is nominally"). Power supply apparatus should average input power rated input power of the maximum at any time 2s. Supplement. aa)  condensed instructions Instructions should be given by a flag or otherwise clearly legible and understandable manner so that sound, and the related risk for defibrillation By ECG monitoring operation. We shall adopt one of the following tests to verify compliance with the requirements. 100lx marker under ambient lighting conditions and distance 1m for normal far vision should be clear and legible. by Standard eye chart or other equivalent methods such as Titmus test sequences to determine visually check concept visual acuity, not less than 20/40 visual acuity Or corrected visual acuity of not less than 20/40. In voice command such noise and 65dB 1m far distance condition for normal human hearing should be clear and understandable. White noise sound level environment is a type of A-weighted sound level meter 2 (see IEC 60651) measuring, will be white noise It is defined as in the range of 100Hz to 10kHz flatness of ± 10%. bb)  internal power supply Any internal power supply and battery charger isolated, as applicable, a brief description shall be marked battery recharging or replacement. If the equipment also connected to the supply network or a separate battery charger, the device shall be used to indicate any operation mark the connection limit. These instructions should include the case with batteries for depleted battery or not. cc) disposable defibrillator electrode Tag appended electrode package shall include at least the following information. 1) Symbol (compliance YY0466) or Chen Shu specified expiration date of the electrode (eg. "before use") and production lot number or GB 9706.8-2009/IEC 60601-2-4.2002 Production Date; 2) the appropriate alerts and warnings, if applicable, including time limits and the case is not immediately used for an electrode used should not be opened Packaging warning information; 3) appropriate use of guidance, including skin preparation before use; 4) if applicable, an indication of requirements relevant storage conditions. And marking instrument controller 6.3 Supplement. aa)  defibrillators should have pre-selected energy controller, unless the device automatically provides pre-energy treatment. Preset energy (including all/menu mode programmable mode) or a corresponding indication, and shall in Joules according to Nominally 50Ω resistive load release energy, to express their value. When the energy reaches the preset, the defibrillator should be given clear instructions. Compliance shall be checked by inspection. 6.8 random file 6.8.2 Manual e), f), g) and h) is replaced with the following. e) Procedure for full charge of any detailed description of the rechargeable battery; f) the replacement cycle recommended primary batteries or rechargeable batteries; g) at ambient temperature 20 ℃, the new, fully charged battery can provide an effective number of discharges the maximum energy (refer to AED The pre-set number of times); h) device for the battery charger is connected to both supply power to a separate but connected, when connected to some kind of connection, all use restrictions Information. This information should include the battery is fully discharged or not attached to the battery. Supplement. aa) Manual Additions Instructions also include the following. 1)  warned not to touch the patient during defibrillation. 2)  should remain inconspicuous police sufficient distance to other electrodes or metal objects in contact with the patient except related defibrillator electrode Report, it must also specify the correct type and method of defibrillator electrodes defibrillator electrode grip in use. It should also inform Medical electrical equipment other non-operator application part defibrillation protection should be disconnected from the patient during defibrillation. 3) inform the operator, to avoid a part of the patient's body (e.g., bare skin of the head or limb) and conductive liquid (such as a conductive Cream, blood and saline solution) into contact with a metal object (such as a bed frame or stretcher), because the metal objects defibrillation lead to unintended Current bypass. 4) all environmental requirements related to equipment limitations before using stored  Pro (such as a vehicle or ambulance in adverse weather conditions Car). 5) In the description of the use of a separate monitoring electrodes for monitoring the process, shall be described in the placement of these electrodes. 6)  alert the operator, regardless of device used or not, they are subject to regular maintenance, in particular. --- cleaner defibrillator electrode insulating portion and the handle may be reusable; --- for all reusable handle or defibrillator electrode sterilization procedures, if applicable, and most sterilization methods recommended by comprising Large sterilization cycle; --- All reusable cleaning monitoring electrode; --- All disposable defibrillator electrode and the monitor electrode all disposable packaging checks confirm complete seal Good and within the validity period; --- cable and possible defects of inspection electrodes of the handle; --- function tests; GB 9706.8-2009/IEC 60601-2-4.2002 --- If a requirement is charged periodically (e.g., electrolytic capacitors or polyvinylidene fluoride (PVDF) capacitance) of the energy storage means Is set, then it is charged. 7)  described fully discharged energy storage device, when the defibrillator is set to the maximum energy charging time, a) at the rated voltage of the power supply network; internal power defibrillator, when a new battery is fully charged; b) according to a) above, but at 90% of the rated voltage of the network; internal defibrillator power, frequently used for Or defibrillator after 6 passes the maximum discharge energy of the non-defibrillator frequently used after 15 times; c) according to b) above, but the measurement start switch from power to the maximum time required to complete the charging energy. 8) on the AED, explained rhythm analysis from the beginning to the maximum time required for discharge readiness, a) at the rated voltage of the power supply network; internal power defibrillator, when a new battery is fully charged; b) according to a) above, but at 90% of the rated voltage of the network; internal defibrillator power, frequently used for Or defibrillator after 6 passes the maximum discharge energy of the non-defibrillator frequently used after 15 times; c) according to b) above, but the measurement start switch from power to the maximum time required to complete the charging energy. 9) of the AED, described in heart rate after the detector has detected identifying shockable rhythm, if it continues to analyze ECG; is No preparation and charging the defibrillator shock; whether defibrillation lead AED entry prohibition state in this case. 10) Warning defibrillator explosion and fire hazard in an environment with flammable or oxygen-enriched gas vehicle. 11) equipment is expected to infrequent use, it should be clearly stated its limitations and correct description of the intended use of the device. It should also Give suggestions or requests for equipment health checks or preventive maintenance. 12) of the device to release energy according to a preset treatment programs, information programs, and on the release of energy treatment selected automatically reset Conditions should be described in the instruction manual. As applicable, including how to use the specification should change regimen Relevant information. 6.8.3 SHEET Supplement. aa)  Sheet should also provide. 1) defibrillation basic performance data. a) by the relationship between time and current or voltage waveforms plotted graphically release pulse. These waveforms are followed When the defibrillator is connected to a resistive load 25Ω, 50Ω, 75Ω, 100Ω, 125Ω, 150Ω and 175Ω resistor, And when set to a maximum output or, if applicable, according to the following treatment protocol automatically a pre-determined energy intake Line; b) the resistance of 50Ω load, the accuracy of energy to release energy; c) If the defibrillator has a mechanism disables the output when the patient impedance exceeds a certain limit, the publication of these limits; 2) Basic Performance Data synchronizer, comprising. a) Meaning sync pulse or marker display; b) whenever the output enable, the maximum delay time between the sync pulse and energy release, including how to measure the delay Time, and c) description of the conditions to cancel the synchronous mode; Basic Performance Data 3) rhythm identification detector, comprising. a) ECG database test report Rhythm ECG database used to confirm the recognition performance should at least comprise. different amplitude ventricular fibrillation (VF) rhythm, different QRS duration and frequency of ventricular tachycardia (VT) rhythm, including various sinus ventricular tachycardia Tachycardia, atrial fibrillation and atrial flutter, having a PVC (external ventricular extrasystoles) characterized in sinus rhythm, and arrest pacemaker rhythm. The There should be detected rhythm recognition algorithm similar manner ECG lead ECG and handling characteristics are classified, And the detection system to have an appropriate length to make a determination. Experiment report describes the recording method, the source of heart rate, heart rate selection criteria, and should provide a method and commentary yl GB 9706.8-2009/IEC 60601-2-4.2002 quasi. The results are reported performance of the detector should include specific, real predictive value, sensitivity and false-positive rate, such as The following table. ID detector 101 in Table rhythm classification VF and VT all other ECG rhythms A B shock No shock C D True positive (A) is the correct classification of a shockable rhythm. True negative (D) is not a shock to display all heart Correct classification law. False positive (B) is a combination of cardiac arrest or fusion rhythm or incorrectly classified as Shockable rhythm. False negatives (C) is a stop associated with cardiac VF or VT incorrectly classified Non-shockable rhythm. Identify shockable rhythm sensit...

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