YY/T 1563-2017 English PDFUS$359.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1563-2017: Spinal implants - Test method for functional, kinematic and wear assessment of total disc prostheses Status: Valid
Basic dataStandard ID: YY/T 1563-2017 (YY/T1563-2017)Description (Translated English): Spinal implants - Test method for functional, kinematic and wear assessment of total disc prostheses Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 18,143 Date of Issue: 2017-03-28 Date of Implementation: 2018-04-01 Issuing agency(ies): State Food and Drug Administration YY/T 1563-2017: Spinal implants - Test method for functional, kinematic and wear assessment of total disc prostheses---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. Spinal implants-Test method for functional, kinematic and wear assessment of total disc prostheses ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Spinal implant total intervertebral disc prosthesis function, Exercise and wear evaluation test method Released on.2017-03-28 2018-04-01 implementation State Food and Drug Administration issued ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. 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 administered by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, orthopedic implants subcommittee (SAC/TC110/ SC1). This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, School of Mechanical Engineering, Xi'an Jiaotong University. The main drafters of this standard. Zhang Shu, Dong Shuangpeng, Wang Ling, Pang Xiaoqiang.IntroductionThe wear was evaluated by the method of mass loss in the test medium defined in the standard. This standard does not address any potential failure modes associated with the fixation of the implant and bone interface. The purpose of this standard is to test different intervertebral disc prostheses under specified conditions and to compare wear and fatigue performance. However, it should be recognized that there are many possible variables in in vivo conditions, and that a single laboratory may not have a simulation by fixed parameters. Representative of all over. Most intervertebral disc prostheses fall into two main categories. ball-and-socket joint prostheses; elastic or compliant prostheses. For the former, this standard is mainly Explain type 1 wear [see 3.13a)]; however, for the latter, this standard describes the movement and/or load of the implant when it is within a certain range. Potential failure modes of the prosthesis under conditions of physiological motion and load range. For joint components, this standard focuses on Type 1 wear testing. Users should be aware that other types of wear may occur, which may It has an effect on the function and performance of the intervertebral disc prosthesis. Therefore, the user should consider the effect of other types of wear on the performance of the prosthesis. In order to make data between different laboratories reproducible and comparable, it is important to establish a uniform test procedure. The subject of this standard It is a trial and data report for the use of a unified disc replacement prosthesis. Due to the lack of important clinical search history of intervertebral disc prosthesis, the actual loading conditions and load curves are not fashionable in writing this standard. The law is described. Therefore, the use of the loads and motion conditions specified in this standard does not necessarily accurately reproduce conditions in the body. Of course, this standard A functional method for evaluating the boundary or endpoint conditions used in the design of the prosthesis is provided. Spinal implant total intervertebral disc prosthesis function, Exercise and wear evaluation test method1 ScopeThis standard specifies test methods for evaluating the wear and/or functional properties of a total intervertebral disc prosthesis. This standard is applicable to the total intervertebral disc prosthesis Guidance on wear and/or fatigue testing under sexual and motor conditions. This standard applies to lumbar and cervical prostheses. Because the loading and movement of the lumbar vertebrae and the cervical vertebrae are inconsistent, this standard Do not elaborate. This standard does not apply to partial disc replacement prostheses, such as nucleus replacement prostheses or facet joint replacement. This standard does not serve as a performance standard. It is the responsibility of the user of this standard to characterize the safety and effectiveness of the prosthesis to be evaluated. This standard is not intended to address all of the security issues involved, even those related to their use. establish Appropriate safety and health practices, as well as the applicability of clear management restrictions prior to application, are the responsibility of the users of this standard.2 Normative referencesThe 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. YY/T 1428 Spinal implant related terminology YY/T 0959 Spinal implant interbody fusion cage mechanical properties test method3 Terms and definitionsThe functional and motor test terminology defined by YY/T 1428 and YY/T 0959, as well as the following terms and definitions, apply to this document. 3.1 Axial load Applied to the upper or lower clamp-endplate, the combined force F-axis of the load that the intervertebral disc prosthesis (original healthy intervertebral disc) is subjected to in the body. Note. For human health intervertebral discs, the primary component force is the axial compression force FZ along the negative Z axis of the global coordinate and passes through the origin of the intervertebral disc prosthesis. In the XY plane The shear forces are FX and FY, respectively. When the axial load does not pass through the origin of the intervertebral disc prosthesis, a lateral bending moment MX around the origin is generated, buckling/stretching Bending moment MY. 3.2 Coordinate system/axis coordinatesystem/axes The overall XYZ Cartesian coordinate system is defined according to the right-handed Cartesian coordinate system. The XY plane is equally divided in the coordinate system to simulate the adjacent vertebral body. The angle between the sagittal plane between the upper and lower surfaces of the endplate. The overall coordinate system is stationary relative to the lower endplate fixture of the intervertebral disc prosthesis, under The side end plate clamp is also stationary relative to the test machine frame. Xyz represents the local Cartesian coordinate system, moving the local Cartesian coordinate system to make it The side end plate clamps are connected and their initial orientation is coincident with the XYZ axis of the overall coordinate system. Specify the upper end plate clamp relative to the lower side Three-dimensional motion of the endplate fixture, and the three-dimensional motion is measured from the rotation of the continuous Euler angle around the xyz axis respectively (z. axis Rotation; x. side bend; y. buckling - extension). 3.2.1 Origin origin The center of the global coordinate system is positioned at the initial position of the instantaneous rotational center (COR) of the total disc replacement prosthesis. Note. Some artificial prostheses do not have a single center of rotation. Instead, there is a movable center of rotation or multiple defined rotations. Heart, it depends on the direction of the movement. In this case, the user should determine the origin according to the definition principle of the origin. 3.2.2 X-axis X-axis Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the forward direction relative to the initial unloaded position of the sample. 3.2.3 Y-axis Y-axis Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the lateral direction relative to the initial unloaded position of the sample. 3.2.4 Z-axis Z-axis Relative to the axis fixed in the overall coordinate system of the tester base, the forward direction is the direction above the initial unloaded position of the sample. 3.2.5 X-axis x-axis Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and can be moved relative to the overall coordinate system, its forward direction is relative to the prosthesis. 3.2.6 Y-axis y-axis Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and movable relative to the overall coordinate system, its forward direction is lateral with respect to the prosthesis. 3.2.7 Z-axis z-axis Relative to the fixed coordinate axis of the intervertebral disc prosthesis, and movable relative to the overall coordinate system, its forward direction is relative to the top of the prosthesis. 3.3 Degraded degradation Loss of material, function or material properties caused by non-wear related causes. 3.4 Liquid absorption fluidabsorption The liquid absorbed by the implant material during the test. 3.5 Functional failure functionalfailure The total failure of the intervertebral disc (IVD) prosthesis due to permanent deformation or wear, or the prosthesis cannot bear the load/motion, or This leads to a reduction in the clinically relevant movement of the prosthesis or a secondary effect of a reduction in the intended movement of the prosthesis. 3.6 Interval net volume wear rate of cycle interval i VRI intervalnetvolumetricwearrateVRiduringcycleintervali VRi= WRi (1) In the formula. ρ---Abrasion material mass density (eg, in g/mm3). Note. VRi, unit. mm3/million cycles. 3.7 Interval net wear rate of cycle interval i WRI intervalnetwearrateWRiduringcycleintervali WRi= NWi-NWi-1 Number of wears in the cycle interval i × 10 6 (2) Note 1. For i=1, NWi-1=0. Note 2. WLi, unit. g/million cycles. 3.8 Intervertebral disc (IVD) prosthesis intervertebraldisc (IVD) prosthesis An abiotic structure intended to restore (or partially restore) the support and movement between adjacent vertebral bodies. 3.9 Motion condition kinematicprofile The relative motion experienced by the intervertebral disc prosthesis between adjacent vertebral bodies. 3.10 Limit limit A significant change in stiffness under a particular motion indicates that the implant has reached the end of its designed range of motion. 3.11 Load condition loadprofile The load that the implant needs to withstand under the applied motion conditions, or the load that the intervertebral disc prosthesis needs to withstand when using load control. 3.12 Mechanical failure mechanicalfailure This may or may not result in work due to material defects (eg, fatigue cracks) or failures due to bonding between materials. Can fail. 3.13 Joint wear design for various wear types wearmodesforarticulatingtypedesigns a) Type 1. It occurs only on the articular surface between the two main bearing surfaces. b) Type 2. occurs between the surface of the primary joint and the secondary, non-load bearing surface. c) Type 3. occurs on the surface of the two main bearing surfaces that are still common as the articular surface, but the three-body particles are already trapped between the two articular surfaces. d) Type 4. Contact and movement that occurs between two minor, non-bearing surfaces. 3.14 Net wear of worn samples NWi netwearNWiofwearspecimen NWi=(W0-Wi) (Si-S0) (3) The mass loss of the test sample is corrected for the amount of absorption of the liquid at the end of the cycle interval i. Note. NWi, unit. g. 3.15 Net volume wear of worn samples NVi netvolumetricwearNViofwearspecimen At the end of the loop interval i NVi= NWi (4) In the formula. ρ---Abrasion material mass density (eg, in g/mm3). Note. NVi, unit. mm3. 3.16 Termination (number of cycles) runout(cycles) The maximum number of cycles a test sample can withstand if no functional failure has occurred. 3.17 Wear wear An incremental mass loss of material due to relative motion between the surfaces of the implant to measure the intervertebral disc prosthesis or intervertebral disc prosthesis The mass loss of the part is characterized. Note. Or in the case of a non-articular surface, a compliant disc prosthesis, wear is simply defined as the mass loss of the prosthesis. Underside of the implant component The interface with the upper side and the bone is not in this definition, see 5.2.2. 3.18 Soak the quality of the control sample Si weightSiofsoakcontrolspecimen S0 is the initial point of the loop interval i, and Si is the end point. Note. Si, unit. g. 3.19 The quality of the worn sample Wi weightWiofwearspecimen W0 is the initial point of the loop interval i, and Wi is the end point. Note. Wi, unit. g.4 Significance and application4.1 This standard is used to determine the fatigue and wear performance of the intervertebral disc prosthesis. The prosthesis needs to undergo a large number of functional and kinematic loads/motion cycles. Rings (eg, different designs, materials, manufacturing processes, and other design parameters for the specific design of the intervertebral disc prosthesis can be used in this standard Line evaluation). 4.2 This standard is intended for use in intervertebral disc prostheses that support the load and transmit motion by forming joints (or using compliant materials). pottery Porcelain, metal, polymeric materials or combinations thereof have been applied to intervertebral disc prostheses. The purpose of this standard is to serve as a guidance document for different materials and classes. Types of prostheses are compared for kinematic wear and/or fatigue.5 test equipment5.1 total intervertebral disc prosthesis parts Total intervertebral disc prostheses may have different shapes and structural compositions. Currently known structural components include ball and socket joints, with one freedom A biconcave joint that moves or semi-constrains the third body, a metal endplate that incorporates an elastic core, and a uniaxial hinge joint. 5.2 Spinal test device 5.2.1 Laboratory room For test machines capable of accommodating multiple sets of samples, the test rooms should be isolated from each other to avoid contamination of the test samples. Test room overall It should be made of corrosion-resistant materials, such as acrylic or stainless steel, and the test chamber can be easily removed from the test machine for testing. Thoroughly clean the test chamber when the test is stopped. 5.2.2 Fixtures/tooling components Since the purpose of the trial was to characterize the wear and/or fatigue of the intervertebral disc prosthesis under functional and kinematic conditions, the group in the test chamber The installation method shall not affect the accuracy of the assessment of mass loss or stiffness variation during the test. For example, with complex expectations and bones Prostheses that contact the upper and lower surfaces of the contact [eg, sintered beads, hydroxyapatite (HA) coating, plasma spray], these prostheses are Specially manufactured to change the surface, this does not affect the simulated wear. 5.2.3 Fixed The implant should be securely (rigidly) attached to the matching test tool at the interface of its bone-implant. 5.2.4 degrees of freedom The movement of the upper tooling relative to the lower tooling shall be unconstrained in three dimensions, unless movement is specified in certain directions. Load. 5.2.5 Load and motion (see Tables 1 and 2 for components) 5.2.5.1 The axial load is the compressive load and is applied in the negative direction along the Z axis. Deviation from the initial position with the movement of the intervertebral disc prosthesis As the shear components FX, FY and bending moments MX, MY. 5.2.5.2 The buckling load and motion are positive moments, and MY and rotation are respectively around the y-axis. 5.2.5.3 The extension load and motion are negative moments, and MY and rotation respectively surround the y-axis. 5.2.5.4 Lateral bending loads and motions are positive and negative bending moments, with MX and rotation surrounding the x-axis, respectively. 5.2.5.5 Torsional loads and motions are positive and negative moments, and MZ and rotation are respectively around the z-axis. Table 1 Cervical intervertebral disc prosthesis test conditions and related parameters Test conditions Axial load Preferred displacement control. Range of motion (ROM)a (°) Alternative load control. Applied bending moment range N·m Flexion/extension 100 ± 7.5 ± 2.0 Side bend / Rotate ±6 ±2.0 ±6 ±4.0 a Users of this standard should determine whether the range of motion is equally divided by buckling and stretching, or more inclined to one of them. Table 2 Lumbar disc prosthesis test conditions and related parameters Test conditions Axial load Cyclic axial load (minimum ~ maximum) Preferred displacement control. Range of motion (ROM) (°) Alternative load control. Applied bending moment a N·m Flexion/Stretch 1200 900~1850 ±7.5b ±10 Rotate 1200 900~1850 ±3 ±10 Side bend 1200 900~1850 ±6 ±12 a General based on a review of range of motion, average flexibility, and stiffness factor. b Depending on the product design, the balance of motion range should be similar to the expected clinical situation. 5.2.6 Frequency The user of this standard should determine and verify the test frequency if there is insufficient proof to ensure that the motion (load) conditions are within the specified tolerances. Within the range, and the wear and functional properties of the intervertebral disc prosthesis are not significantly affected, the frequency should not exceed 2 Hz, see 6.1.5. 5.2.7 Loop Counter A complete cycle is to go through the entire motion interval from the starting position (or to the entire load interval when the load is controlled) and back A complete interval of the starting position (load). The number of cycles is counted using an automatic counting device.6 reagents and materials6.1 Test medium 6.1.1 Dilute to 20 g/L bovine serum solution with deionized water as the test medium. 6.1.2 In order to inhibit bacterial growth, serum should be stored refrigerated before the test. In addition, the test medium should contain 0.2% sodium azide (or other Applicable antibiotics or antibiotics to prevent the growth of microorganisms (mold, yeast, bacteria, etc.), microbial growth will reduce the lubrication of serum Force, and contaminate samples of wear particles extracted from serum. Other lubricants should be evaluated to determine suitable storage conditions. 6.1.3 It is recommended to add 20mmol/L ethylenediaminetetraacetic acid (EDTA) to the serum to bind the calcium in the solution and reduce the carrying table. Precipitation of calcium phosphate. Calcium phosphate deposition has been shown to severely affect friction and wear properties, especially for polyethylene/ceramic composite surfaces. If will EDTA is added to other test media and should be evaluated. 6.1.4 The overall temperature of the test medium shall be maintained within the range of (37 ± 3) °C unless otherwise specified. 6.1.5 Users should be aware that typical uninterrupted joint wear simulations result in higher actual temperatures of the load bearing surface and/or contact lubricant. Body temperature, that is, motion is usually interrupted periodically. Temperature increases are related to a range of factors, including but not limited to joint friction, materials Hysteresis, implant-tooling material conductivity, design and test frequency. 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