GB 16174.1-1996 Cardiac pacemakers Part 1: Implantable cardiac pacemakers
Some standard content:
National Standard of the People's Republic of China
Cardiac pacemakers
Part 1: Implantable pacemakers GB 16174.1—1996
ISO 5841-1:1989
This standard is equivalent to the international standard ISO5841-1:1989 "Cardiac pacemakers - Part 1: Implantable cardiac pacemakers". 0 Introduction
0.1 ISO5841-1 is the first part of a series of standards for cardiac pacemakers. ISO5841-2 deals with the reporting of clinical performance of commonly used pulse generators.
ISO5841-1 was jointly developed by a working group of ISO() and IEC. During the development process, the European Community used it as a basis for coordinating the regulatory requirements that were being considered by several European countries at the time. This coordinated effort has resulted in some important improvements, especially in the areas of environmental and electrical hazard testing.
0.2 International standards for medical electrical equipment in general do not apply to battery-powered pacemakers implanted in the human body for therapeutic purposes. The focus of implantable cardiac pacemakers is not on the patient environment, which is the focus of general medical electrical equipment standards, and is generally considered to be safety outside the patient. It is generally recognized that special clinical situations may require the use of pacemakers that do not fully comply with the requirements of ISO5841. 0.3 Fundamentally, pacemakers are used to treat arrhythmias. Arrhythmias reduce cardiac output and may cause confusion, dizziness, coma, and even death. Implantable cardiac pacemakers are an effective treatment and have restored health to countless patients. The purpose of a pacemaker is to restore a heart rhythm and cardiac output that is appropriate to the patient's physiological needs. Due to different factors, patients may have single or variable arrhythmias, which require a variety of treatment methods. In order to meet this need, a variety of pacemakers have been introduced. Recently, there are also cardiac pacemakers with adjustable operating modes and characteristics to meet the changing requirements of patients at the time of implantation and thereafter. In the past, implantable cardiac pacemakers had limited reliability and lifespan, and the benefits they brought to patients were also limited. Now, implantable cardiac pacemakers are constantly adopting new technologies to maximize the benefits for patients. The lifespan and reliability of pacemakers have been improved. The need for patients to undergo reoperation has been reduced, and the risks they bear have been greatly reduced. The standard requirements for cardiac pacemakers focus on information that helps to select and use such devices. Standardization work should also confirm that clinical experience plays a leading role in evaluating the design of pacemakers, and that consistent production specifications play a leading role in ensuring the quality, reliability and biocompatibility of each manufactured pacemaker. The degree of certainty in determining how a pacemaker will work for a particular patient based on tests conducted according to a set of technical indicators is limited. Some tests and requirements are still under consideration, and some technical issues remain to be resolved. 1 Scope and Field of Application
1.1 This standard establishes basic terms and definitions, and specifies the marking and packaging requirements for implantable cardiac pacemakers. It also specifies minimum requirements and corresponding test methods for the environmental stress resistance of pacemaker pulse generators. Appendix A explains the codes that distinguish the operating modes of the pulse generator. Appendix B presents test methods to confirm that the basic electrical parameters meet the requirements. Appendix C describes the estimation and expression of the nominal service life of the pulse generator. Appendix D provides an example of a technical information card. Appendix E is the rationale for certain clauses of this standard. Appendix F is the optional symbols that can replace written text. 1.2 This standard applies to all fully implantable cardiac pacemakers, but does not cover the anti-tachyarrhythmia and defibrillation functions of the pacemaker, nor does it cover isotope battery-driven pacemakers (nuclear pacemakers). 2 Reference standards
GB2423.5 Basic environmental testing procedures for electric and electronic products Part 2: Test methods Test Ea and guidance: Shock GB2423.10 Basic environmental testing procedures for electric and electronic products Part 2: Test methods Test Fc and guidance: Vibration (sinusoidal) GB2808 Full digital date writing method
IS) 5841-2 Cardiac pacemakers XI Part 2: Clinical performance report of commonly used pulse generators 3 Definitions
3.1 Basic definitions
For common use worldwide, the following definitions are formulated: The terms proposed in Clause 3.1.4 are specific to the mode of pulse generator and use the codes described in Appendix A. 3.1.1 Atrial blanking at ventricular pace The interruption of atrial sensing during the cardiac hydrogen pulse. 3.1.1.1 atrial-ventricular (AV) interval the time interval between an atrial pulse or sensed atrial depolarization and the subsequent ventricular pulse or sensed ventricular depolarization. 3.1.1.2 ventricular-atrial (VA) interval the time interval between a ventricular pulse or sensed ventricular depolarization and the subsequent atrial pulse or sensed atrial depolarization. 3.1.2 battery depletion indicator the amount of battery charge that has been depleted during the life of the pulse generator. 3.1.3 blanking period the period during which the pulse generator loses its ability to sense a pulse. 3.1.4 pulse generator mode (see 3.2.24) Note: The three-letter code for each term is explained in Appendix A. 3.1.4.1 atrial asynchronous mode (AOO) atrial asynchronous mode in which both ventricular and atrial sensing are lost and atrial pacing is independent of cardiac activity. 3.1.4.2 Atrial inhibited mode (AAI) atrial inhibited mode In this mode, ventricular function is lost or absent. If an atrial beat is sensed during the escape interval, the pulse generator inhibits atrial pacing. If no atrial beat is sensed during the escape interval, the pulse generator provides atrial pacing at the fundamental rate. 3.1.4.3 Atrial triggered mode (AAT) atrial triggered mode In this mode, ventricular function is lost or absent. If an atrial beat is sensed during the escape interval, an atrial pulse is immediately provided synchronously with the atrial beat. If no atrial beat is sensed during the escape interval, the pulse generator provides atrial pacing at the fundamental rate. 3.1.4.4 AV sequential mode, asynchronous In this mode, atrial and ventricular sensing function is lost or absent, and the pulse generator provides atrial pacing at the fundamental rate. At the end of the specified AV interval after each atrial pulse, the pulse generator provides a ventricular pulse, regardless of cardiac activity. 3.1.4.5 AV sequential mode with ventricular sense (inhibition)
In this mode, atrial sensing is lost or absent, and if no ventricular beat is sensed before the end of the escape interval, the pulse generator provides atrial pacing at the basic rate. If no ventricular beat is sensed during the specified AV interval, a ventricular pulse is provided at the end of the AV interval. If a ventricular beat is sensed at any time, a new ventricular-atrial interval begins. 3.1.4.6 AV sequential mode, ventricular synchronized-187
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(triggered)
In this mode, atrial sensing function is lost or does not exist. If no ventricular beat is sensed before the end of the escape interval, the pulse generator provides atrial pacing at the basic rate. If no ventricular beat is sensed during the specified atrioventricular interval, a ventricular pulse is provided at the end of the atrioventricular interval. If a ventricular beat is sensed at any time, a ventricular pulse is immediately provided and a new ventricular-atrial interval is started.
3.1.4.7 Atrioventricular sequential mode (multimode) with dual-chamber sensing and dual-chamber pacing (HF,DDD) AV sequential mode with sensing and pacing in both chambers (universal) If the atrial beat is not sensed and the ventricular beat is not sensed, the pulse generator provides atrial pulses and cardiac pulses at the fundamental rate. The following two modes are used:
DII: In this mode, the atrial beat interrupts the atrial escape interval of the pulse generator without releasing an atrial pulse; the ventricular beat interrupts the ventricular escape interval and starts a new ventricular escape interval without releasing a ventricular pulse. DDI)D: In this mode, the atrial beat interrupts the AV interval of the pulse generator and starts an AV interval without releasing an atrial pulse. Then, if no ventricular beat is sensed during the AV interval, a ventricular pulse is provided at the end of the AV interval, unless the maximum tracking rate has been exceeded. If a ventricular beat is sensed at any time, a new ventricular-atrial interval is started without releasing a ventricular pulse. If the AV interval cannot be interrupted by the ventricular beat, as a result, the ventricular pulse is still released, the system is said to be "unsensed". 3.1.4.8 Ventricular asynchronous mode (VO0) ventricularasynchronous In this mode, atrial function and ventricular sensing are lost. The pulse generator provides ventricular pulses at the basic rate independent of cardiac activity. 3.1.4.9 Ventricular inhibited mode (VVI) ventricular inhibited In this mode, atrial function is lost or absent. If the ventricular sensing function senses a beat interval shorter than the escape interval, the pulse generator inhibits ventricular pacing. If no ventricular beat is sensed during the escape interval, the pulse generator provides ventricular pacing at the basic rate.
3.1.4.10 Atrial synchronized mode (VAT) atrial synchronized In this mode, ventricular sensing and atrial pacing are lost or absent. When an atrial beat is sensed, the set atrial-ventricular interval begins and a ventricular pulse is provided at the end of the interval, unless the maximum tracking rate has been exceeded. If no atrial beat is sensed during the escape interval, the pulse generator provides ventricular pacing at the basic rate. 3.1.4.11 Atrial synchronized, ventricular inhibited mode (VDD) atrial synchronized, ventricular inhibited In this mode, both atrial and ventricular sensing functions are available, but atrial pacing function is lost or absent. When an atrial beat is sensed, the set AV interval begins. If no ventricular beat is sensed during the AV interval, a ventricular pulse is delivered at the end of the interval, unless the maximum tracking rate has been exceeded. If neither an atrial beat nor a ventricular beat is sensed during the escape interval, the pulse generator delivers ventricular pacing at the base rate. If a ventricular beat is sensed at any time, a new ventricular-atrial interval begins. 3.1.4.12 Ventricular triggered mode (VVT) ventricular triggered In this mode, atrial function is lost or absent. If a ventricular beat is sensed during the escape interval, a ventricular pulse is delivered immediately in sync with the ventricular beat. If no ventricular beat is sensed during the escape interval, ventricular pacing is delivered at the base rate. 3.1.4.13 Beat
The orderly autonomous activity of the heart.
3.2 Definitions for use in this standard
The following definitions apply only to this standard.
3.2.1 Adapter
Specialized connector used between incompatible pulse generators and electrode catheters. 3.2.2 Basic pulse interval basic pulse interval The pulse interval that is not changed by the sensed ECG or other electrical effects. 3.2.3 Basic rate basic rate
The pulse rate of the atrial and ventricular pulses of the pulse generator, which is not changed by the sensed ECG or other electrical effects. 188
3.2.4 Electrode
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Conductive element (usually the terminal of the electrode catheter) used to form an interface with human tissue. 3.2.5 Escape interval The time between a sensed heartbeat or pulse and the subsequent non-trigger pulse of the pulse generator. 3.2.6 Lead
Electrode connection device between the pulse generator and the heart. 3.2.7 Bipolar (multipolar) lead An electrode catheter with two (or more) independent electrodes. 3.2.8 Endocardial lead An electrode catheter with electrodes in contact with the endocardium or the inner surface of the heart. 3.2.9 Epicardial lead An electrode catheter with electrodes in contact with the epicardium or the outer surface of the heart. 3.2.10 hysteresis
Characteristic data of a pulse generator, the difference between the escape interval after a sensed cardiac beat and the basic pulse interval. Note: The escape interval is generally longer than the basic pulse interval, which is called "positive" hysteresis. 3.2.11 unipolar lead unipolar lead with two electrodes.
3.2.12 marking
Any written, printed or graphic mark appearing on or affixed to the pacemaker or its packaging. 3.2.13 model designation The name and/or a group of letters and numbers used by the manufacturer to distinguish the function or type of one pacemaker from another. 3.2.14 nominal pulse generator service life An estimate of the expected implant life of a pulse generator of a given type; in making this estimate, the effective capacity of the battery is taken into account to keep the performance characteristics of the pulse generator within the limits under specified conditions, but the possibility of any failure other than battery exhaustion is not taken into account.
3.2.15 Pacemaker
A device that stimulates the heart, consisting of a pulse generator and an electrode catheter. 3.2.16 Package
Any container or packaging material that contains, places or encloses a pacemaker in whole or in part. 3.2.17 Shipping package A supply package that contains a pulse generator, electrode catheter or accessories, or any combination thereof, and is specially designed to protect the storage package during transportation.
3.2.18 Sterilized package A package that contains a pulse generator, electrode catheter/accessories, or a combination thereof, and that has been sterilized by an approved sterilization method. 3.2.19 Storage package A package designed by the manufacturer to protect the contents during storage at the implantation center. 3.2.20 Pulse
Single-phase electrical output of a pulse generator used to stimulate the myocardium. 3.2.21 Dual chamber (ADJ) Dual chamber for atria and ventricles.
3.2.22 Transvenous
A term describing access to the heart via a vein. 3.2.23 Pulse amplitude
The amplitude of the pulse, expressed in volts or amperes. 3.2.24 Pulse duration
GB 16174.1-1996
The pulse width measured between the reference points specified in this standard (see Appendix B). 3.2.25 Pulse generator The part of the pacemaker that generates periodic electrical pulses, which includes the power supply and electronic circuits. 3.2.26 Pulse interval The time interval between equivalent points of two consecutive pulses, expressed in milliseconds. 3.2.27 Pulse rate
The number of pulses per minute, expressed in ptpm. 3.2.28 Interference pulse frequency The pulse frequency at which the pulse generator responds when it senses electrical activity that does not come from the myocardium and is considered to be interference. Note: The interference pulse frequency is the preset
3.2.29 Test pulse frequency testpulserate The pulse frequency of the pulse generator when it is directly affected by the test device. 3.2.30 Refractory period The period during which the pulse generator is insensitive to signals other than the specified type of input signal. 3.2.31 Sensitivity
The minimum signal required to continuously control the function of the pulse generator, in millivolts. 3.2.32 J serial number
A unique combination of letters and/or numbers selected by the manufacturer to distinguish a particular pacemaker from other pacemakers of the same model. 3.2.33 sterilebzxz.net
The state of a product in which no living organisms are present; the product has been sterilized and remains sterile under appropriate protection (e.g. packaging). 3.2.34 sterilized treated by an approved sterilization method.
3.2.35 use-before date
The date specified by the manufacturer, after which the pulse generator should not be implanted in the human body. 3.2.36 input impedanceinput impedanceFor a pulse generator, the electrical impedance appearing at its terminals in response to the test signal (see B1.4 of Appendix B), which is considered to be equal to the impedance appearing when sensing a heartbeat. 3.2.37 insertion diameterinsertion diameterThe smallest diameter of a rigid cylinder through which an electrode catheter can be inserted. 4 Packaging, marking and accompanying documents (see Appendix E for rationale) 4.1 Packaging and marking
4.1.1 Packaging
Packaging can be divided into:
a) transport packaging (optional);
b) storage packaging;
c) sterilization packaging.
4.1.2 Packaging marking - general requirements
Each package must have a clear mark that will not adversely affect the packaged items. The marking material should be able to keep the mark clear during normal handling of the package.
Note: The codes defined in Article 3.1.4 and Appendix A can be used in the marking and accompanying documents instead of words to indicate the mode of the pulse generator. 490
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All dates must be expressed in numbers in the order of year-month-day in accordance with the provisions of GB2808. 4.2 Transport packaging
4.2.1 Contents of transport packaging
The transport packaging must include storage packaging
4.2.2 Transport packaging marking
The transport packaging marking must include the following contents. a) The name and postal address of the manufacturer, and the name and postal address of the agent or distributor (if different from the name and address of the manufacturer).
b) Major warnings regarding handling and storage during transportation 4.3 Storage packaging
4.3.1 Storage packaging marking
Any warnings must be clearly marked. The storage label must include the following: a) the manufacturer's name or registered trademark, and the manufacturer's postal address; b) if applicable, a blank space for the agent's name, postal address and telephone number; c) the contents of the sterile packaging, i.e. the pulse generator (model, type, serial number at the time of shipment) and/or the electrode tube (model, type, serial number) and/or adapter; d) the main pacing mode and the pacing mode at the time of shipment; e) the pulse generator at 37(2(, load 500Q±5%). The following non-programmed parameters of the device (nominal parameters at the time of delivery): 1) Basic pulse frequency, in ppm;
2) Pulse amplitude, in V or mA;
3) Pulse width, in ms;
4) Sensitivity, in mV;
f) A brief statement that the contents of the package have been treated with an approved sterilization method; g) Expiration date (see 4.1.2);
h) Recommendations on storage and use operations; i) Connector structure (monopolar or bipolar or multipolar). 4.3.2 Contents of the storage package
The purchase and storage package must include the sterilization package.
Note: The random documents (see 4.4) can be provided together with each storage package, or they can be provided separately with the pacemaker, electrode catheter or pulse generator. 4.4 Random Documents
The documents accompanying the pacemaker (i.e., pulse generator, electrode catheter or adapter) must include: a) Clinician's Manual (see 4.4.1); b) Registration Form (see 4.4.2); c) Patient Identification Card (see 4.4.3); d) Removal Record Form (see 4.4.4); e) Special Technical Information Card (see 4.4.5). 4.4.1 Clinician's Manual
4.4.1.1 The manual must give the following information about the pulse generator or electrode catheter or adapter: a) Trade name, postal address and telephone number; b) Instructions for use, including:
1) Instructions for opening the sterile packaging;
2) Recommendations for management, including storage and environmental conditions. c) If a pulse generator is supplied, the pulse generator information must be provided in accordance with Article 4.4.1.2; 191
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d) If an electrode catheter is supplied, the electrode catheter information must be provided in accordance with Article 4.4.1.3; e) If an adapter is supplied, the adapter information must be provided in accordance with Article 4-4.1.4. 4.4.1.2 If a pulse generator is supplied, the manual must include the following information: a) model and name (if applicable); b) a general description and explanation of the available functions and, for each available pacing mode (see note to 4.1.2), a description of how each heart interacts with the pulse generator; c) the name of the power supply manufacturer and the type of battery used; d) the configuration of the connector (monopolar, bipolar or other) and/or the geometry and/or dimensions of the connector seat; e) physical characteristics, including:
1) mass, in g;
2) principal dimensions, in mm;
3) volume, in ml.
4) a general description of materials in contact with human tissue; f) if the electrode is an integral part of the pulse generator, the material, surface area (in mm2) and shape of the electrode must be specified; g) applicable procedures and possible adverse effects if a programmer other than that specified by the manufacturer is used h) Unless otherwise specified, electrical performance indicators (including tolerances, if necessary) at 37°C ± 2°C and 500Ω ± 5% load; 1) The range of fundamental frequency, test pulse frequency, escape and interference pulse frequency and the corresponding pulse interval (if applicable); 2) The range of allowable variation of fundamental pulse frequency within the specified initial time (if applicable); 3) Pulse shape (such as graphical representation), and identification points indicating pulse output amplitude and width; 4) Pulse amplitude;
5) Pulse width
6) Input impedance (if applicable);
7) Positive and negative sensitivity range and description of the waveform used; 8) Refractory period (pacing and sensing) and atrioventricular interval (if applicable); 9) Operating performance in electric, electromagnetic and magnetic field environments; 10) The value/range of programming parameters of specific programmers; 11) The setting of emergency function parameters of each programmer (if applicable); 12) Frequency limit (unrestrained protection), in pulses per minute. Note: The method for measuring these characteristics is shown in Appendix B. i) Information on the relationship between the battery exhaustion indicator and the pulse generator performance measured at 37°C ± 2°C and a load of 5000 ± 5% and the relationship between the battery exhaustion indicator and the pulse generator performance and the mode. If applicable, the following should be included: 1) Basic pulse frequency (in ppm) and basic pulse interval (in ms); 2) Test pulse frequency (in ppm) and test pulse interval (in ms); 3) Pulse width (in ms);
4) Pulse amplitude (in V or mA);
5) Sensitivity (in mV);
6) Mode change.
The characteristic change used as a battery exhaustion indicator in Appendix C must also be clearly indicated. i) Information on typical changes of the following performance of the pacemaker with temperature in the range of 20℃ to 43℃ (e.g., expressed in graphs or curves): 1) basic pulse frequency (in ppm) or basic pulse interval (in ms); 2) test pulse frequency (in ppm) or test pulse interval (in ms); 3) pulse width (in ms);
1) pulse voltage (in V or mA);
5) sensitivity (in m)
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k) Information on non-destructive identification (see 4.6.2); 1) Connector types and recommendations on the selection of appropriate electrode leads, as well as information on certain applicable adapters; m) Specific considerations for electrode lead connections at the time of implantation; n) Recommended methods for verifying the integrity of implanted pacemakers; 0) Warnings on the effects of therapeutic energy sources (such as external cardioversion, diathermy, cautery or other similar energy sources); p) Recommendations for the handling of pulse generators removed from the body; q) The nominal service life of the pulse generator under specified conditions (see Annex C); r) If applicable, a statement to the effect of service life experience data (see ISO5841-2). 4.4.1.3 If electrode leads are supplied, they must be in accordance with 4.4.1.1d) requires the following information to be provided: a) type, model and designation (if applicable); b) conductor, connector pin | conductor/insulator material and general description of shape, material and construction of electrodes; c) physical dimensions (including tolerances, if possible) 1) length (in cm);
2) external surface area of electrode (in mm2); 3) insertion diameter of transvenous electrode catheter (excluding connector terminal) (in mm); 4) distance between electrodes of bipolar or multipolar endocardial electrode catheter (in mm); 5) maximum penetration depth of epicardial electrode catheter; 6) connector geometry (length and diameter, in mm). d) The resistance of the conductor (in α);
e) Recommendations related to the use of the pulse generator; ") Specific considerations for the connection of the electrode lead during implantation; g) Instructions for use to avoid damage to the electrode lead. 4.4.1.4 If an adapter is supplied, the following information must be provided in accordance with Section 4.4.1.1: a) Construction (monopolar, bipolar, multipolar), model and name (if applicable); b) Materials used for conductors, connector pins and insulators, and a general description of the shape, material and construction of the electrodes; c) Compatibility with the pulse generator and electrode lead. 4.4.2 Registration form
The registration form must be made in two copies. One of the copies is marked "Return to the manufacturer". The form must leave space to record at least the following information about the patient and the implant:
a) The patient's gender, age and pacing indication; b) The pulse generator's Type, model and serial number; c) Selected pacing mode:
d) Pulse generator implantation date (written in accordance with the method specified in GB2808); e) Pacemaker electrode catheter type, model and serial number, and implantation date (written in accordance with the method specified in GB2808); f) Implantation center name, postal address and telephone number, and name of responsible physician; g) Physician/hospital address.
4.4.3 Patient Identification Card
The manufacturer must provide an identification card to the implantation center with each pulse generator. A blank space must be left on the card to record at least the following information when applicable:
a) Patient name and identification code suitable for computer data processing; b) Name, address and telephone number of the implantation center performing the pacemaker implantation surgery; c) Name of the physician responsible for the patient;
d) Name of the pacemaker manufacturer or agent; GB 16174.1-1996
e) Date of implantation of the pulse generator and electrode lead f) Model and serial number:
g) Pacing mode selected (specific) and the most important pacing mode: h) Selected pulse generator frequency (basic/test pulse frequency) and pulse width; i) Type, model and serial number of the electrode lead, and the name of the manufacturer. 4.4.4 Pulse generator extraction record sheet
A extraction record sheet with blank space for recording basic information must be provided. This sheet shall be at least Two copies, one of which is marked "return to the manufacturer". The removal record must contain the following basic information: a) Patient's condition;
b) Name of the implantation center;
c) Name and address of the physician responsible for removing the implant; d) Manufacturer, type, model, serial number and implantation and removal date of the removed pulse generator; e) Reason for removal of the pulse generator
Significant change in pulse generator performance, preventive replacement (selective replacement) or other reasons. 4.4.5 Special Technical Information Card || tt||The manufacturer must provide a special technical information card with each pulse generator. The card must contain at least the following information: a) manufacturer's name or trademark, and postal address; b) pacing mode available (see Appendix A); c) type or model; d) serial number; e) validity period (written in accordance with the method specified in GB2808); f) sterilization method; g) sterilization date (written in accordance with the method specified in GB2808); h) measured at 37°C ± 2°C, 500Q ± 5% load. Pulse generator function (according to factory settings); 1) basic pulse frequency (in ppm), basic pulse interval (in ms); 2) test pulse frequency (in ppm), test pulse interval (in ms); 3) pulse amplitude (in V or mA);
4) pulse width (in ms);
5) sensitivity (in mV);
6) pacing mode at factory;
7 whether it is programmable;
8) refractory period after pacing pulse (in ms). i) factory set frequency limit (in ppm) j) connector structure;
k) battery exhaustion indicator;
1) identification of programmable features.
Note: For an example of the format of the technical information card, see Appendix D. 4.5 Sterile packaging
4.5.1 Contents of sterile packaging
The pulse generator, electrode catheter and necessary accessories/adapters (whether alone or in combination) must be supplied in a sterile packaging that can maintain the sterility of the product during transportation or normal storage and use operations, so that the items provided can be used in a sterile state. The sterile packaging should be designed to be clearly visible once it has been opened. Even if the package has been resealed, it can be seen that it has been opened before.
4.5.2 Sterilization package marking
The sterilization package marking must include the following information GB 16174.1-1996
a) manufacturer's name or registered trademark, and factory location; b) the contents of the sterilization package, namely the pulse generator (model, serial number) and/or electrode catheter (type, model, serial number) and/or adapter (model);
c) the non-programmable performance data of the pulse generator measured at 37C±2 (, 500Q main 5% load) (nominal value at the time of leaving the factory): 1) basic pulse frequency (in ppm);
2) test pulse frequency (in ppm); 3) pulse amplitude (in V or mA);
4) sensitivity (in mV);
5) pulse width (in ms).
d) The most important pacing mode available and the pacing mode at the time of shipment; e) Instructions that the package and its contents have been sterilized by an approved method; f) Expiration date (written in accordance with the method specified in GB2808); g) Warnings must be clearly stated;
h) Opening instructions to avoid physical damage and maintain sterility; i) Connector structure (monopolar, bipolar or multipolar). 4.6 Pulse generator, electrode catheter and adapter 4.6.1 Marking of pulse generator
The marking on the pulse generator must be permanent, legible and give the following information: a) The name and location of the manufacturer;
b) The most important pacing mode available;
c) Model;
d) Serial number, with the words "SERIALNUMBER" or "SN". 4.6.2 Non-invasive identification of pulse generators
Non-invasive identification of pulse generators shall be by means of radiopaque letters, numbers and/or symbols forming a code unique to a particular pulse generator. The identification mark shall be placed inside the pulse generator so that the clinician can identify it in a non-invasive manner with the aid of applicable code information. The identification mark shall at least indicate the manufacturer and the unique model of the pulse generator. 4.6.3 Markings on leads and adapters Each lead and each adapter (if possible) shall be permanently and clearly visible with the manufacturer's identification mark and serial number mark.
5 Protection against environmental stresses See Appendix E for a justification. 5.1 Vibration test
5.1.1 Requirements
When tested in accordance with 5.1.2, the performance of the pulse generator shall comply with the performance requirements specified in 4.4.5h) 1) to 6). 5.1.2 Test method
Perform a sinusoidal vibration test on the pulse generator in accordance with the provisions of (B2423.10); the following test conditions must be met (see the footnote of Appendix E):
a) Frequency range: 5Hz~500Hz;
b) Vibration displacement/acceleration (peak value); 5Hz~20Hz: displacement 3.5mm;
----20Hz500Hz acceleration 25m/s*;
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c) Sweep: 5/500/5Hz.1 octave/min; d) Number of sweeps: three times in each of the three mutually perpendicular axes; e) Duration: 30min in each direction. After the test, check whether the pulse generator meets the requirements specified in 5.1.1. 5.2 Impact test
5.2.1 Requirements
When testing according to 5.2.2, the same requirements specified in 5.1.1 must be met. 5.2.2 Test method
According to GB2423.5.2.1. The pulse generator is subjected to an impact test. The following test conditions must be met: a) Pulse waveform: half-sine wave; b) Intensity: - peak acceleration: 5000m/s*, - pulse duration: 1ms. c) Direction and number of impacts: once in each of the two directions of the three mutually perpendicular axes (i.e., six times in total); the axes should be selected so as to be most likely to expose the fault. After the test, check whether the pulse generator meets the requirements specified in 5.2.1. 5.3 Temperature cycle 5.3.1 Requirements When the test is carried out in accordance with 5.3.2, the same requirements specified in 5.1.1 must be met. 5.3.2 Test method a) Reduce the temperature of the pulse generator to the minimum value specified by the manufacturer or 0°C (whichever is higher) and maintain the temperature for 24h±15min. b) Raise the temperature to 50℃±0.5℃ at a frequency of 0.5℃/min±0.1C/min and maintain the temperature for 6h±15min. c) Lower the temperature to 37℃±0.5℃ at a frequency of 0.5℃/min±0.1C/min and maintain the temperature for 24h±15min. After the test, check whether the pulse generator meets the requirements of 5.3.1. 6 Protection against electrical hazards
6.1 Defibrillation
6.1.1 Requirements
Each output and input of the pacemaker must have a considerable degree of protection so that after the attenuation of a defibrillation pulse and a time delay of twice the escape interval, neither the synchronization performance nor the stimulation performance will be affected. When testing in accordance with 6.1.2, the measured values must comply with the provisions of 5.2.1. 6.1.2 Test method
6.1.2.1 Overview
The pulse generator is connected to a defibrillation test circuit consisting of an RCL (resistance-capacitance-inductance) series loop (see Figure 1) through a 3002±2% resistor. The parameters of R, C, and L are as follows: C = 330 μF ± 5%
1 13.3 mH ±1%
R.+R:= 10 2± 2%
武中; R
-Inductor Resistance
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Re-—Output resistance of the defibrillation pulse generator. Output peak value is 140V ± 5%
Test the pulse generator with three consecutive positive pulses (+140V) at intervals of 20s; after a 60s pause, repeat the test with three consecutive negative pulses (-140V) at intervals of 20s. Check the performance of the pulse generator, which shall not be affected. 6.1.2.2 Unipolar pulse generator
Connect the pulse generator to the defibrillator pulse generator through a 300Ω ± 2% resistor (see 6.1.2.1 and Figure 1). Test the pulse generator according to the pulse sequence described in 6.1.2.1. R charging
Pulse generator
Figure 1 Test circuit of defibrillator pulse generator for test impulse voltage resistance 6.1.2.3 Bipolar pulse generator
Connect each electrode lead terminal and metal casing of the pulse generator to the defibrillator pulse generator through a 300Ω resistor in turn for testing. If the casing is covered with insulating material, immerse the pulse generator in a metal container filled with physiological saline, connect the casing to the container, and test the pulse generator according to the pulse sequence described in 6.1.2.1. 6.1.2.4 Other pulse generators
For pulse generators with more than one input or output, test each electrode lead terminal as described in 6.1.2.3. 6.2 Electrical neutrality of implantable pacemakers (no leakage current) 6.2.1 Requirements
When tested in 6.2.2, no leakage current greater than 0.1μuA shall be measured on any current channel. 6.2.2 Test method
6.2.2.1 Connect the input and output terminals of each pulse generator to a DC oscilloscope through an input resistor of 100k2 for at least 5 minutes. Measure the voltage value displayed on the oscilloscope just before a pulse. It shall not exceed 10mV. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, the casing resistance shall not be less than 5M2.
6.2.2.2 Sequentially
a) Connect each pair of pulse generator terminals through a DC resistance meter; b) Connect each input or output terminal of the pulse generator to the metal casing through a DC resistance meter. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, its resistance shall not be less than 5M2.
6.3 Electromagnetic compatibility (EMC)
Under consideration.
6.4 High-frequency surgery test
Under consideration.
6.5 Biocompatibility1 Connect the input and output terminals of each pulse generator to a DC oscilloscope through an input resistor of 100k2 for at least 5 minutes. Measure the voltage value displayed on the oscilloscope just before a pulse. It shall not exceed 10mV. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, the casing resistance shall not be less than 5M2.
6.2.2.2 Sequentially
a) Connect each pair of terminals of the pulse generator through a DC resistance meter; b) Connect each input or output terminal of the pulse generator to the metal casing through a DC resistance meter. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, its resistance shall not be less than 5M2.
6.3 Electromagnetic compatibility (EMC)
Under consideration.
6.4 High-frequency surgery test
Under consideration.
6.5 Biocompatibility1 Connect the input and output terminals of each pulse generator to a DC oscilloscope through an input resistor of 100k2 for at least 5 minutes. Measure the voltage value displayed on the oscilloscope just before a pulse. It shall not exceed 10mV. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, the casing resistance shall not be less than 5M2.
6.2.2.2 Sequentially
a) Connect each pair of terminals of the pulse generator through a DC resistance meter; b) Connect each input or output terminal of the pulse generator to the metal casing through a DC resistance meter. Test each pair of terminals and between each terminal and the metal casing. When the applied voltage is not higher than 0.5V, its resistance shall not be less than 5M2.
6.3 Electromagnetic compatibility (EMC)
Under consideration.
6.4 High-frequency surgery test
Under consideration.
6.5 Biocompatibility
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