YY/T 0809.13-2020 English PDFUS$149.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0809.13-2020: Implants for surgery--Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components Status: Valid
Basic dataStandard ID: YY/T 0809.13-2020 (YY/T0809.13-2020)Description (Translated English): Implants for surgery--Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 8,888 Date of Issue: 2020 Date of Implementation: 2021-01-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies a method for determining the torque required to loosen the fixation of the femoral head of a hip prosthesis (in which the ball is not expected to rotate relative to the neck) under specified laboratory conditions. This standard applies to femoral components of partial or total hip prostheses in which the femoral head and the femoral neck/stem (hereafter referred to as the cone) are fixed together by conical locking or other means, in which the femoral head and cone are independent components, which are made of metallic or non-metallic materials. This standard does not cover methods for examining the specimen; specimen inspection shall be negotiated between the testing laboratory and the specimen provider. YY/T 0809.13-2020: Implants for surgery--Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components---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. Implants for surgery--Partial and total hip joint prostheses--Part 13.Determination of resistance to torque of head fixation of stemmed femoral components ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implant parts and total hip prostheses Part 13.Stem Femoral Head Fixation Determination of torsional moment 2020-02-21 released 2021-01-01 implementation Issued by the State Drug Administration Table of contentsPreface Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Principle 1 5 Device 1 6 Step 2 7 Handling of samples 4 Reference 5ForewordYY/T 0809 "Surgical Implant Parts and Total Hip Joint Prostheses" is expected to be divided into the following parts. ---Part 1.Classification and dimensioning; ---Part 2.Metal, ceramic and plastic joint surfaces; ---Part 4.Fatigue performance test and performance requirements of shank femoral components; ---Part 6.Neck fatigue performance test and performance requirements of the femoral component with handle; ---Part 8.Fatigue performance of shank femoral components with torque effect; ---Part 10.Determination of the static resistance of the combined femoral head; ---Part 12.Test method for acetabular cup deformation; ---Part 13.Determination of the fixed anti-torsion moment of the head of the shank femoral component. This part is part 13 of YY/T 0809. This section was drafted in accordance with the rules given in GB/T 1.1-2009. This part uses the redrafting method to modify and adopt ISO 7206-13.2016 ``Surgical Implant Parts and Total Hip Joint Prostheses Part 13 Minutes. Determination of the anti-torsion torque of the head of the shank femoral component. Compared with ISO 7206-13.2016, this part has the following technical differences. ---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace ISO 7500-1 with GB/T 16825.1 equivalent to the international standard; ● Replace ISO 7206-1 with YY/T 0809.1 equivalent to the international standard; ● Replace ISO 7206-10 with YY/T 0809.10 modified to adopt international standards; ● Figure 1 and Figure 2 swap the sequence. - The brand name was deleted in 6.3.3. Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is organized by the Orthopedic Implant Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/ SC1) Centralized. Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China) Co., Ltd., Shanghai University School of Electrical Engineering and Automation, Beijing Natong Technology Group Co., Ltd. The main drafters of this section. Dong Shuangpeng, Li Wenjiao, Chen Changsheng, Wang Jian, Hua Zikai, Cai Peng, Li Renyao, Zhao Wenwen. Surgical implant parts and total hip prostheses Part 13.Stem Femoral Head Fixation Determination of torsional moment1 ScopeThis part of YY/T 0809 specifies that the fixation of the hip joint prosthesis femoral ball head is loosened under specific laboratory conditions. (In hip prostheses, the ball head is expected to be unable to rotate relative to the neck) The method of torque required. This part is applicable to the femoral components of partial or total hip prostheses, in which the femoral ball head and the femoral neck/stem (hereinafter referred to as the cone) are connected Over-cone locking or other ways to fix together, in which the femoral ball head and cone are independent parts, they are made of metal or non-metallic materials production. This section does not include the method of inspecting the sample; the inspection of the sample should be negotiated between the testing laboratory and the sample provider.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 16825.1 Inspection of static uniaxial testing machine Part 1.Inspection and calibration of force measuring system of tensile and (or) compression testing machine Standard (GB/T 16825.1-2008, ISO 7500-1.2004, IDT) YY/T 0809.1 Surgical implant parts and total hip joint prostheses. Part 1.Classification and dimensioning (YY/T 0809.1- 2010, ISO 7206-1.2008, IDT) YY/T 0809.10 Surgical implant parts and total hip joint prostheses. Part 10.Determination of the static resistance of the combined femoral head (YY/T 0809.10-2014,ISO 7206-10.2003,MOD)3 Terms and definitionsThe terms and definitions defined in YY/T 0809.1 and YY/T 0809.10 apply to this document.4 PrincipleApply a static torque to the femoral ball head/cone assembly of the hip prosthesis and increase the torque until it reaches the gap between the femoral ball head and cone. The connection fails or the selected maximum torque is reached (without failure).5 equipment5.1 The testing machine, in accordance with the requirements of GB/T 16825.1, should have the following characteristics. ---Axial pressure can be applied through the axis of the femoral ball head/cone for assembly, and the full scale accuracy is 1%; ---Axial force can be applied to a specific point on the lever arm of the cone unit, or the cone unit can be directly applied without the lever arm Torque is applied, and the full scale accuracy is 1%; --- There is a monitoring device that can record the load value and angular displacement value applied to the sample, with a tolerance of ±0.5°. 5.2 Cone unit, including a cone that is assembled with the femoral ball head in actual use, or a replica of the cone, which is the same as the cone Size and made of the same material, using the same manufacturing process and the same specifications. 5.3 The loading tooling should be able to withstand the expected load, and its design can make the line of action of the external torque and the femoral ball head/cone assembly center The heart lines are collinear, as shown in Figure 1. Figure 1 Schematic diagram of the test device with suggested dynamic and motion boundary conditions6 steps6.1 Specimen and sample size In order to determine the torque that loosens the fixation of the femoral ball head in the hip prosthesis, at least the cone unit of each ball head should be tested 5 pieces. Each specimen shall contain a femoral ball head and the femoral neck intended to be fixed to it. The sample can be a real implant or a substitute sample composition. 6.2 Assembly (installation) of test piece Assemble the femoral ball head and cone unit according to YY/T 0809.10. 6.3 Femoral ball head fixation 6.3.1 Optional method 1, process two parallel planes on the ball head near the equator, and the distance between these two planes and the center of the ball head is perpendicular Basically the same, as shown in Figure 2. Figure 2 An example of preparing a femoral ball head that is locked and fixed with parallel planes The two planes facilitate the use of a flat wrench to fix the femoral ball head to resist axial torque. The perpendicular distance between the two parallel planes should be at the femur Within the range of 30% to 70% of the average diameter of the ball head. The remaining wall thickness of the ball head on the plane should be at least 2.0mm. Note. For 28mm femoral ball head, a vertical distance of 19.0mm±0.5mm is suitable. 6.3.2 Optional method two, you can bond the femoral ball head into a metal ball socket, the ball socket should be able to cover at least 140 ° spherical head hemisphere. The separation torque of the bonded part should be greater than the expected separation torque of the femoral ball head/cone assembly. If the bonding interface is expected at the femoral ball head Before the rotation is broken, it must be recorded in the test report. A sample should be added for testing. Note. Epoxy adhesives have been found to be suitable for bonding the ball head to the tooling. 6.3.3 Optional method three, use pouring resin to embed the ball head in the embedding tooling. The separation torque of the embedding medium/femoral ball head should be greater than the expected separation torque of the femoral ball head/cone assembly. If the interface is on the ball head Destruction before rotation is expected, it should be recorded in the test report. A sample should be added for testing. Note. Pouring resin has been found to be suitable for fixing the ball head. 6.4 Fixing torque of femoral ball head 6.4.1 Install the femoral ball head/cone assembly in the tooling described in 6.3. The alignment of the femoral ball head/cone axis, the femoral ball head tooling axis and the axis of the load torque is necessary to avoid deviations in the results of. During the process of installing the femoral ball head/cone assembly on the test device and applying the torque load until the separation limit is reached, the test device is Should be able to meet the axis alignment. Ideally, this can be achieved by ensuring 5 degrees of freedom (DOF) of the fixed femoral ball/cone assembly, That is, the tooling only prevents rotation around the femoral ball head/cone axis, and can move and rotate freely within a certain range in other directions (see Figure 1). 6.4.2 At a loading rate of 20Ncm/s±4Ncm/s, if not feasible, continuously align the cone at a rotation rate of 0.05°/s±0.01°/s The body unit applies increasing torque; record the applied torque-time or angle-time. 6.4.3 Increase the load until the following conditions occur. a) The recorded load curve reaches its peak and begins to decline; b) When the torque limit of 50N m is reached, the sample is considered to be strong enough at this time; c) The angle limit of 20° is reached, which means that the test should be terminated. If it can be shown that this rotation occurred in the test machine tooling or tooling And the sample (such as fixing glue), then the test should not be counted in 5 samples. 6.4.4 Remove the femoral ball head/cone assembly from the testing machine and tooling, and check the damage of the sample, especially the cone head and cone hole. area. 6.4.5 Report the torsional moment and the angular displacement at the end of the test and its reasons (see 6.4.3). 6.5 Performance standards The sample provider (customer) should specify the acceptance standard of torque, which should be equal to or higher than the existing hip joint femoral ball that has been successfully used in clinical practice Torque of the head/cone assembly. The acceptance criteria shall include the lower limit of the average torque and the lower limit of the torque of each specimen. 6.6 Test report The test report should include the following information. a) Reference to this section; b) Femoral ball head sample information, provided by the sample provider, including the manufacturer's name, femoral ball head diameter, cone length and material; c) The information of the cone sample is provided by the sample provider, including the manufacturer's name, cone material, taper and cone diameter; d) Description of the method of fixing the femoral ball head of the sample and the control sample, including (according to 6.3.1) the vertical distance between parallel planes, The average diameter of the femoral ball head, the remaining wall thickness in the plane position, the length of the lever arm; or the type of glue used, the coverage angle of the ball socket (When fixed in accordance with 6.3.2); or the type of resin used to embed the ball head in the tooling, and the angle at which the resin covers the ball head (according to 6.3.3 Fixed); e) The loading rate or displacement rate used in the test, the maximum torque and the corresponding angle applied before the ball head starts to rotate relative to the cone; f) When applicable, the test results required by the sample provider; g) For each sample tested, confirm the statement of termination of the test; h) After the test, the result of the inspection of the damaged sample can be observed.7 Handling of samplesAll components, even if there is no change in appearance after passing the test, cannot be used for clinical purposes after the test. Care should be taken when using components for further mechanical testing, because the loading mechanism may have changed the mechanical properties of the specimen. This type of test usually results in the transfer of material from one part to the other and changes in the properties of the two mating surfaces. In particular, regardless of Whether it is a cone component or a femoral ball head component, it is not recommended for further testing of the method described in this section. references ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0809.13-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 0809.13-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0809.13-2020_English with my colleagues?Answer: Yes. 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