YY/T 0492-2017 (YY/T0492-2017, YYT 0492-2017, YYT0492-2017)
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Implantable cardiac pacing lead
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YY/T 0492-2017
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Standards related to: YY/T 0492-2017
| Standard ID | YY/T 0492-2017 (YY/T0492-2017) | | Description (Translated English) | Implantable cardiac pacing lead | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.40.040 | | Word Count Estimation | 22,241 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY/T 0492-2004 | | Drafting Organization | Shanghai Medical Device Testing Institute | | Administrative Organization | National Medical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Technical Committee (SAC/TC 10/SC 5) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 0492-2017
Implantable cardiac pacing lead
ICS 11.40.040
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0492-2004
Implantable cardiac pacemaker electrode lead
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 term 1
4 Technical requirements 2
4.1 Physical size 2
4.2 Appearance 3
4.3 Measurement of electrical characteristics of electrode wires 3
4.4 Protection against mechanical damage 6
4.5 Protection against temperature change damage 9
4.6 X-ray detectability 9
4.7 Accelerated aging life experiment 9
4.8 Chemical performance requirements 10
4.9 Sterilization 10
4.10 Protection against biological effects 11
4.11 Packaging, marking 12
4.12 Random File 13
Appendix A (Normative) Chemical Performance Test 15
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0492-2004 "Implanted cardiac pacemaker lead".
Compared with YY/T 0492-2004, the main changes of this standard are as follows.
--- Change the name of the standard to "Implanted cardiac pacemaker electrode lead";
--- Increased electrode lead pacing impedance and perceptual impedance requirements;
--- Increased the requirements for ray detectability;
---Modified the method of life test;
--- Modified the requirements for sterilization residues;
--- Increased particle release requirements;
--- Increased biological evaluation requirements for hemolysis;
--- Revised the requirements for random files with reference to the ISO 14708 series of standards.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is determined by the National Medical Electrical Apparatus Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This standard was drafted. Shanghai Medical Device Testing Institute.
The main drafters of this standard. Zhang Yidong, Xia Jie.
The previous versions of the standards replaced by this standard are.
---YY/T 0492-2004.
Implantable cardiac pacemaker electrode lead
1 Scope
This standard specifies the technical requirements, test methods and markings of implantable cardiac pacemaker electrode leads (hereinafter referred to as "electrode leads").
Packaging, transportation and storage requirements.
This standard applies to implantable cardiac pacemaker electrode leads. The characteristics of the electrode wire connector are YY/T 0491-2004 and
YY/T 0972-2016 (ISO 27186). This standard applies to a pacemaker system consisting of different electrode leads and pulse generators.
There is no requirement for functional compatibility or reliability.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Preparation of GB/T 601 chemical reagent standard titration solution
GB/T 2423.22-2012 Environmental testing - Part 2. Test methods Test N. Temperature change (IEC 60068-2-14.
2009, IDT)
GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000, IDT)
GB/T 16175-2008 Medical silicone material biological evaluation test method
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residues (ISO 10993-7.1995, IDT)
GB/T 16886.18-2001 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005,
IDT)
GB 18279 Medical device ethylene oxide sterilization confirmation and conventional control (ISO 11135.1994, IDT)
GB/T 19633 final sterilization medical device packaging (ISO 11607.2003, IDT)
GB 16174.2-2015 Surgical implants - Active implantable medical devices - Part 2. Cardiac pacemakers (ISO 14708-2.
2005, IDT)
YY/T 0466.1 Medical devices for use in medical devices - Labels, markings and information provided - Part 1 . General requirements
(ISO 15233-1.2007, IDT)
YY/T 0491-2004 Small-section connector for cardiac pacemaker implantable cardiac pacemakers (ISO 5841-3.2000, IDT)
YY/T 0972-2016 Four-pole connector system for active implantable medical device implantable heart rhythm adjustment system size and test
Seeking (ISO 27186.2010, IDT)
3 terms
YY/T 0491-2004 and GB 16174.2-2015 (ISO 14708-2) and the following terms and definitions apply to this
file.
3.1
Adapter adaptor
A dedicated connector for implantable pulse generators and electrode leads that are not compatible with each other.
3.2
Electrode electrode
A conductive portion (usually the tip end of an electrode lead) used to contact body tissue or body fluids.
3.3
Electrode lead
An electrical connection between the pulse generator and the heart.
3.4
Unipolar electrode wire unipolarlead
There is only one electrode of the electrode lead.
3.5
Bipolar electrode wire bipolarlead
An electrode lead having two electrodes, the two electrodes being insulated from each other.
3.6
Multipole electrode wire multipolarlead
An electrode lead having two or more electrodes, and any two electrodes are insulated from each other.
3.7
Guidewire guidewire
A flexible device used to guide the electrode lead through the vein into the heart and to assist in the positioning of the electrode lead (extracted after successful positioning).
3.8
Shaped wire stylet
The wire inserted into the electrode lead provides the auxiliary rigidity and controllability required to operate the electrode in place.
3.9
Guide sheath introducer
A flexible tube inserted into the blood vessel, usually placed over the dilator, through which the electrode can be inserted into the blood vessel after the dilator is withdrawn.
3.10
Marking
Printed content on medical devices, packaging or labels.
3.11
Label label
A label attached to a medical device or package, but not part of a medical device or package.
4 Technical requirements
4.1 Physical dimensions
4.1.1 Physical dimensions of the electrode leads
The physical dimensions of the electrode leads shall include at least the following, including tolerances.
--- Length (in cm);
--- Insertion diameter of the transvenous electrode lead (excluding the connector end) (in mm) and the applicable introducer size (in
French);
--- the distance between the electrodes (bipolar or multi-pole electrode leads) (in mm);
--- If applicable, the maximum depth of insertion into the tissue (in mm);
--- Connector geometry should conform to the published connectors [YY/T 0491-2004 and YY/T 0972-2016 (ISO 27186) regulations
The standard, if different from the published standard, is to provide the depth and diameter of the hole (in mm).
Test. Use a ruler, vernier caliper or micrometer to measure the dimensions of the various parts of the electrode lead length or radial. Electrode when measuring
The wires should be placed flat on a clean, smooth surface and should not be tensioned or stretched.
4.1.2 Surface area of the electrode tip
The surface area of the electrode tip should be published in a random file, expressed in mm2
Compliance is confirmed by examining the design analysis files provided by the manufacturer.
4.1.3 Guide sheath
The electrodes should pass through the guide smoothly under straight and curved conditions and are not damaged.
Test. Place the introducer sheath on a smooth, dry surface, insert the electrode lead completely into the introducer sheath, tear the introducer sheath, and remove the electrode, but
The electrode lead cannot be elongated, and no damage or obvious cracks should occur at any position of the electrode lead.
4.2 Appearance
The appearance of the surface should be smooth, smooth, no sharp edges, rough surfaces or obvious flaws. The joints should be free of flash and blistering.
Cracking and deformation.
It should be checked to confirm its compliance.
4.3 Measurement of electrical properties of electrode wires
4.3.1 General requirements
The value of the electrical properties of the electrode lead measured in accordance with the method described in this clause shall fall within the numerical range specified by the manufacturer in the random document.
Inside (see 4.12).
In order to simulate the conductive effect between the electrode and the myocardial interface, a salt solution beaker containing 0.9 g/L (1±10%) concentration is required as a test.
For the test, the concentration of the salt solution was 1/10 of the isotonic saline solution and was maintained at a temperature of 37 ° C ± 2 ° C.
The nominal input impedance of the oscilloscope used in the test should be 1 MΩ.
The accuracy of the measurement system for each test item should fall within the limits given in Table 1.
Table 1 Accuracy limits of the measurement system
Test item accuracy
Electrode wire DC resistance (4.3.2) ±5%
Electrode wire pacing impedance (4.3.3) ±15%
Electrode wire sensing impedance (4.3.4) ±15%
4.3.2 Electrode wire DC resistance (Rc)
Procedure. When measuring the electrode lead conductor resistance (Rc), an ohmmeter should be used between the electrode wire connector port and the electrode.
The result is expressed in ohms (Ω).
4.3.3 Electrode wire pacing impedance (Zp)
Step. Using the test body, an oscilloscope and a test signal generator, the output impedance is 50Ω.
For a monopolar electrode lead. an inertial electrode of a pacing system is simulated by two sheets of titanium metal plate immersed in the test body. Diameter of the lower metal plate
(d) should be ≥ 50mm. The diameter of the upper metal plate should be 0.8d. The spacing between the two metal plates should be 1.2d. The opening in the upper metal plate cannot be made
Its area is reduced by more than 10%.
The electrode lead was inserted into the test body so that the tip end of the electrode was approximately in the center of the beaker. As shown in Figure 1, the test signal generator should pass
A 33μF ± 5% series film capacitor (CF) is connected to the electrode leads, the metal plate, and the oscilloscope.
Figure 1 Determination of pacing impedance of monopolar electrode lead
If it is at least 15mm away from the electrode in the test and reduces the total conductive area between the two metal plates by no more than 10%, then
To add a non-conductive support around the beaker. Use non-conductive supports internally or externally to control electrode leads if needed
The position of the electrode.
For bipolar electrode leads. Insert the electrode leads into the test body so that the electrodes are at least 10 mm from the edge of the liquid. As shown in Figure 2, try
The signal generator should be connected to the electrode lead and the oscilloscope through a 33μF (1±5%) series film capacitor (CF).
Figure 2 Determination of pacing impedance of bipolar electrode lead
Set the test signal generator to provide negative pulse, 65min-1±5min-1, pulse amplitude 4V±0.1V, pulse width 0.5ms
±0.05ms.
The current of the electrode lead is determined by measuring the voltage drop across the 10 Ω (1 ± 2%) resistor (R). Use the mean of voltage and current through
The following formula calculates the electrode wire pacing impedance (Zp).
Zp=R×
Tp
(V1-V2)dt
Tp
V2dt
Note. The definitions of V1 and V2 are shown in Figures 1 and 2.
The result is expressed in ohms (Ω).
4.3.4 Electrode wire sensing impedance (Zs)
Step. use the test body, an oscilloscope and a test signal generator (output impedance ≤ 1kΩ, the signal provided is defined in Figure 3
Waveform).
Figure 3 Signal waveform generated by the test signal generator
The test signal was introduced by a titanium metal plate immersed in the test body. The diameter of the lower metal plate (d) should be ≥ x 25mm, where x is the test time
The length between the outer edges of the electrodes (measured along the electrode leads) is sensed and d ≤ 50 mm. The diameter of the upper metal plate should be 0.8d. Two metal plates
The spacing should be 1.2d. The opening in the upper metal plate does not reduce its area by more than 10%.
If it is at least 15mm away from the electrode in the test and reduces the total conductive area between the two metal plates by no more than 10%, then
To add a non-conductive support around the beaker. Use non-conductive supports internally or externally to control electrode leads if needed
The position of the electrode.
For a monopolar electrode lead. Insert the lead wire into the test body so that the tip end of the electrode is approximately at the center of the beaker. As shown in Figure 4, the test
The signal generator should pass 500Ω (1±1%) resistance (RF) and 33μF (1±5%) series film capacitor (CF) with metal plate, electricity
The pole wire is connected to the oscilloscope. The oscilloscope input is shunted through a switch and variable resistor (R).
Figure 4 Determination of the perceptual impedance of a monopolar electrode
For bipolar electrode leads. insert the electrode leads into the test body so that the electrodes are equidistant from the two metal plates, and any active electrodes are
The plates are at least 15 mm apart. As shown in Figure 5, the test signal generator should pass 500Ω (1 ± 1%) resistance (RF) and 33μF (1 ±
A 5%) series film capacitor (CF) is connected to the metal plate, electrode leads, and oscilloscope. Oscilloscope input through a switch and variable resistor
(R) Diversion.
Turn on the switch and adjust the test signal generator so that the oscilloscope displays its peak voltage as 10mV±0.2mV, and the tip of the electrode senses one.
Negative pulse. Then close the switch and adjust the resistor R until the amplitude of the leading edge of the signal measured by the oscilloscope drops to 5mV ± 0.1mV.
Figure 5 Determination of the perceptual impedance of the bipolar electrode lead
Measure the resistance R. The result is equal to the electrode wire sense impedance (Zs).
The result is expressed in ohms (Ω).
4.4 Protection against mechanical damage
4.4.1 Tensile load test
Implantable electrode leads should withstand the mechanical loading forces that may occur after implantation, and any wires or joints should not break, any functionality
The electrical insulation layer should not be broken.
Test procedure. use a pretreatment tank (about 9g/L salt solution, 37 ° C ± 5 ° C), tensile load tester, resistance meter, test tank (about
9g/L salt solution, 37°C±5°C, the reference electrode sheet in the tank has an inert metal surface with an area of at least 500mm2), leakage current test
Detector (applicable 100V voltage and provide at least 2mA current).
The sample to be tested should be in the factory state.
The sample should be completely immersed in the pretreatment tank for at least 10 days. Before the test, the electrode lead is rinsed with distilled or deionized water and then the surface is applied.
The moisture is wiped off.
Mount the electrode lead on the tensile tester, sandwiching the metal surface of the electrode lead connector pin and the head end of the electrode lead
Suitable location. Measure the distance between the two grips.
Applying a tensile load to the electrode leads limits the elongation of the wire to 20%, otherwise it increases the tensile force to at least 5N. Pull
The extension load should be applied for at least 1 min and then removed.
The above tensile load should be applied between each combination of the electrode tip and the electrode wire connector pins.
Note 1. Several electrode leads can be used as test samples to complete the test.
The electrical continuity should be verified by measuring the DC resistance of each conduction path.
The insulation integrity of each electrode lead shall be verified and the outer layer (except for any portion within 20 mm of the conductive surface) shall be immersed in the test.
groove. After the test sample is taken out from the pretreatment tank, it should be placed in the test tank within 30 minutes. Before the test, the test sample should be immersed in the test tank.
At least 1h inside. When the test sample is placed in the test tank, the distance between the main body and the reference electrode sheet should be between 50mm and.200mm.
Note 2. Care should be taken during the test to ensure that the exposed conductive surface is insulated from the salt solution.
Then, the insulation between each conductor and the reference electrode should be loaded with a DC test potential of 100V ± 5V;
A 100V ± 5V DC test potential should also be applied between conductors that are exposed to exposed conductive surfaces of human tissue. The test potential should be
The full amplitude value is reached within 0.1s~5s. The test potential shall be maintained at a full amplitude value for at least 15 s before it drops to zero.
If the following is true, the compliance can be confirmed.
--- The electrode lead exhibits a permanent elongation of no more than 5% (unless the manufacturer of the electrode lead indicates that it allows for a longer permanent extension)
Long), there is no permanent functional damage;
--- Continuity measurement results should be in accordance with the manufacturer's regulations;
--- During the voltage loading, each conductor and reference electrode and any two exposed conductive surfaces that may contact human tissue
The leakage current measured between the conductors should be ≤ 2 mA.
4.4.2 Bending fatigue test
Implantable electrode leads should be able to withstand the bending stresses that may occur after implantation and do not cause any wire breakage.
Step. Two tests should be performed. Test 1 was applied to each segment of the electrode lead having the same flexibility. Test 2 applied to electrode wires
The part that is connected to the connector.
Whether it is a complete electrode lead or an electrode lead segment, the test sample should be pretreated as if it were a fully assembled product.
The test should be carried out in a dry, room temperature environment.
Test 1. Use a special fixture (see Figure 6). The inner hole of the device should be no more than 110% of the diameter of the measured portion of the electrode lead. in
At the lower end of the device, the inner surface forms a bell mouth with a certain radius. When the test section is attached to the contour of the device, the center line of the test section is formed.
Centerline bending radius of 6mm ± 0.1mm (see Figure 6).
Figure 6 Wire bending fatigue test device
The unit shall be mounted on a machine that will oscillate the unit from a vertical position to θ = 90° 0° - 5°, thereby forcing the inside of the device bell
The test section is curved. The electrode lead test section should be mounted vertically on the fixture. If the test section can be bent in multiple directions, choose the worst.
Inferior bending conditions were tested.
At the lower end of the test section, a soft thin wire should be passed through the center of the test section plus a load, the weight of which ensures the centerline of the test section is fitted.
Bending radius. For electrode lead bodies without external through holes, a minimum tensile load can be applied directly to the test section, making it fit just tightly
radius.
The device shall oscillate at least 47,000 times at an angle of about 2 Hz on both sides in the vertical direction at an angle of θ=90° 0°-5°.
Note. Adjust the center of oscillation between the test device and the centerline of the test section to reduce vibration.
The above test should be repeated for each of the different flexible sections of the electrode lead.
If the measured resistance on each conduction path is in accordance with the manufacturer's specifications (according to the length of the wire segment of the electrode being tested), and
And each conduction path function is intact, and its manufacturer's performance indicators can be achieved, and compliance can be confirmed.
Test 2. Use a special fixture (see Figure 7), similar to the pulse generator connector head. Fixing device application hard material
The fillet has a maximum radius of 0.5 mm that will be in contact with the electrode lead connector. Make the cavity depth the most allowed in the relevant standards
Small value, if using other connector systems, based on the manufacturer's connector metrics. In addition to cavity depth and fillet radius, the test
The cavity dimensions shall be in accordance with Figure 2 and Figure 7 of Figure 2 of YY/T 0491 (IS-1) or YY/T 0792 (ISO 27186) (Quadrupole Connector), as
If other connector systems are used, they should be based on the manufacturer's specifications.
The fixture should be mounted on a machine that can swing the unit ±45° ± 2° from the vertical position (see Figure 7). Swing center
Located on the plane of the corner where the fixture begins to oscillate. The fixing device should make the electrode wire connector and its electrode wire segment droop by gravity
Straight suspension. The electrode lead connector should be installed in the fixture, selected for the worst test conditions, and fixed with a set screw.
Figure 7 Connector bending fatigue test device
A load shall be suspended at the lower end of the test electrode wire segment, 10 cm ± 0.5 cm from the center of the swing of the fixture. The load connecting device should
Make sure there is no relative movement between the conductor and the fixed point line. The load (including the connecting device) weighs 100g ± 5g.
The fixing device oscillates at least 82000 times at an angle of θ=±45°±2° on both sides in the vertical direction at a frequency of about 2 Hz.
The above test should be repeated for each connector on the electrode lead.
If the measured resistance on each conduction path is in accordance with the manufacturer's specifications (according to the length of the wire segment of the electrode being tested), and
And each conduction path function is intact, and its manufacturer's performance indicators can be achieved, and compliance can be confirmed.
4.4.3 Retention test
Implantable connectors for electrode leads should be able to be identified in different types. The retention of the implanted connector should be greater than or equal to 5N.
The manufacturer shall state the post-implantation performance and verify it by the following tests.
Note. This test is only applicable to connector systems without fixing screws and/or electrode lead connectors that are not compatible with fixing screws.
Test. According to the manufacturer's instructions, the implantable connector is selected and inserted, immersed in a salt solution tank of about 9g/L, the temperature is 37 ° C ±
5 ° C, at least 10d.
After removal from the salt solution, each pair of connectors shall receive a continuous tensile force. 5N ± 0.5N, 7.5N ± 0.5N and 10N ± 0.5N, each
The pulling force lasts at least 10s.
Recording the maximum tensile force that does not cause the connector to disengage is the test result (see 4.12).
4.5 Protection against temperature change damage
The electrode leads are designed and constructed to ensure that temperature changes that may be experienced during transport or storage do not cause irreversible changes.
Test. Nb should be tested according to the provisions of GB/T 2423.22-2012, only for active implantable medical care in aseptic packaging under the following conditions
The implanted portion of the device was tested.
a) low temperature. the minimum storage temperature claimed by the manufacturer, or -10 °C ± 3 °C (whichever is lower);
b) high temperature. the highest storage temperature claimed by the manufacturer, or 55 °C ± 2 °C (whichever is higher);
c) Temperature change rate. (1 ± 0.2) ° C/min.
After the above test, if the following contents are met, the compliance can be confirmed.
--- Continuity measurement results should be in accordance with the manufacturer's regulations;
--- During the voltage loading, each conductor and reference electrode and any two exposed conductive surfaces that may contact human tissue
The leakage current measured between the conductors should be ≤ 2 mA.
If the temperature is not -10 ° C ± 3 ° C and 55 ° C ± 2 ° C, it should be recorded together with the test results.
4.6 X-ray detectability
The electrode leads are clearly visible under X-rays.
Test. X-ray detectability of electrode leads should be performed u......
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