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YY/T 0346-2022 English PDF (YYT0346-2022)

YY/T 0346-2022 English PDF (YYT0346-2022)

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YY/T 0346-2022: Implants for osteosynthesis - Metallic fixation screw for femur neck
This document specifies the terms and definitions, requirements, test methods, manufacturing, sterilization, packaging, and information provided by the manufacturer of metallic fixation screws for the femur neck (hereinafter referred to as femur neck screws). This document applies to femoral neck screws, which are used for the internal fixation of femur neck fractures during orthopedic surgery.
YY/T 0346-2022
YY
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 35
Replace YY/T 0346-2002
Implants for osteosynthesis - Metallic fixation screw for
femur neck
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 1, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Requirements ... 6
5 Test methods ... 9
6 Manufacturing ... 11
7 Sterilization ... 11
8 Packaging ... 11
9 Information provided by the manufacturer ... 11
Appendix A (Informative) List of approved method standards for chemical analysis, metallographic examination ... 13
Appendix B (Normative) Explanation of the determination method of maximum torque and breaking angle ... 14
Appendix C (Normative) Measuring method of the axial insert strength of a femur neck screw ... 15
Appendix D (Normative) Test methods of static compression bending performance and fatigue compression bending performance of femur neck screws ... 18
References ... 22
Implants for osteosynthesis - Metallic fixation screw for
femur neck
1 Scope
This document specifies the terms and definitions, requirements, test methods, manufacturing, sterilization, packaging, and information provided by the manufacturer of metallic fixation screws for the femur neck (hereinafter referred to as femur neck screws).
This document applies to femoral neck screws, which are used for the internal fixation of femur neck fractures during orthopedic surgery.
2 Normative references
The following documents contain the provisions which, through normative reference in this document, constitute the essential provisions of this document. For the dated referenced documents, only the versions with the indicated dates are applicable to this document; for the undated referenced documents, only the latest version (including all the amendments) is applicable to this document.
GB 4234.1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture
GB/T 13810 Wrought titanium and titanium alloy for surgical implants
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB 23102 Implants for surgery - Metallic materials - Wrought titanium - 6aluminium-7niobium alloy
YY 0018 Implants for osteosynthesis - Metallic bone screws
YY/T 0343 Liquid penetrant inspection of metallic surgical implants
YY 0605.9 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
YY/T 0640 Non-active surgical implants - General requirements
YY/T 0662 Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical requirements and test methods
YY/T 0856 Implants for orthosynthesis - Metallic angled fixation device YY/T 1074 Implants for surgery - Measuring method for pitting corrosion potential on stainless products
YY/T 1504 Implants for surgery - Test method for determining the axial pullout strength of metallic bone screws
YY/T 1505 Implant for surgery - Test method for determining the self-tapping performance of metallic bone screws
YY/T 1506 Implants for surgery - Test method for driving torque of metallic bone screws
3 Terms and definitions
The terms and definitions defined in YY 0018, YY/T 0856, and the followings apply to this document.
3.1 metallic fixation screw for femur neck
An implant that is made of metallic materials, used alone or in conjunction with other implants (such as angle fixers, intramedullary nails, and internal fixation plates) during femur neck fracture surgery, and implanted in the femur neck.
3.2 axial insert strength
The maximum pressure required to fully insert the working part of the femur neck screw, which is implanted into the human body by percussion (see Figure C.1 in Appendix C), into the test block, and the unit is Newton (N).
4 Requirements
4.1 Materials
Femur neck screws shall be preferably made of surgical implant materials specified by international standards, national standards, and industry standards.
Note: This item is only applicable to self-tapping femur neck screws implanted into the human body by screwing in.
4.2.7 Static compression bending performance
The manufacturer shall specify the compression bending strength and compression bending stiffness of femur neck screws.
4.2.8 Fatigue compression bending performance
The manufacturer shall specify the fatigue compression bending performance of femur neck screws.
4.3 Corrosion resistance
The pitting potential (Eb) of the stainless-steel femur neck screw shall not be less than 800 mV.
4.4 Surface quality
4.4.1 Surface defects
The surface of the femur neck screw must have no discontinuities.
4.4.2 Surface roughness
The manufacturer shall specify the requirements for the surface roughness (Ra) value according to the product design characteristics.
4.4.3 Appearance
The surface of the femur neck screw shall be free from defects such as oxide scale, knife marks, small notches, scratches, cracks, depressions, sharp edges (except cutting edges), burrs, and shall also be free from inlays, final processing deposits, and other pollutants.
4.4.4 Anodic oxidation surface treatment
After anodic oxidation surface treatment, femur neck screws shall at least be conducted a qualitative analysis of surface elements and evaluation of cytotoxicity. 4.5 Dimensions
The manufacturer shall specify the dimensions and tolerances of the product according to the product design characteristics.
4.6 Coordination performance
Where the femur neck screw has a connection, the coordination performance shall be good, and there must be no looseness or jamming.
5 Test methods
5.1 Materials
The chemical composition and microstructure shall be sampled on the final product, and inspected according to the method specified in the selected material standard or the method in the standard recommended in Appendix A.
5.2 Mechanical properties
5.2.1 Maximum torque and breaking angle
The test shall be carried out according to the method of YY/T 0662 and the instructions in Appendix B. If an electronic torsion testing machine is used for the torsion test, the range shall be selected to ensure that the recorded maximum torque and breaking angle are within the effective range of the testing machine. If possible, counting from the thread close to the screw head, there shall be 5 complete threads exposed; if less than 5 threads are completely exposed, it shall be indicated in the report. It is recommended to use a fixed angular velocity of 3 r/min, rotate the femur neck screw in the direction of insertion until the femur neck screw breaks, and record the maximum torque and breaking angle. The samples shall not be less than 5 pieces.
5.2.2 Hardness
The test shall be carried out according to the method specified in GB/T 4340.1, and the number of samples shall not be less than 3 pieces.
5.2.3 Axial insert strength
The test shall be carried out according to the method specified in Appendix C, and the number of samples shall not be less than 3 pieces.
Note: The test method in Appendix C is not the only method for measuring the axial insert strength of the femur neck screw, and the enterprise can also formulate the test method by itself according to the product design characteristics.
5.2.4 Axial pullout strength
The femur neck screw implanted into the human body by screwing-in shall be tested in accordance with the method specified in YY/T 1504. The femur neck screw implanted into the human body by percussion can be subjected to the axial pullout strength test with reference to the method specified in YY/T 1504 after the test in 5.2.3. The number samples shall not be less than 3 pieces.
5.4.3 Appearance
It shall be inspected by normal or corrected vision, and the number of samples shall not be less than 3 pieces.
5.4.4 Anodic oxidation surface treatment
Qualitative analysis of surface elements shall be carried out by using a scanning electron microscope and energy-dispersive spectrometer, and the cytotoxicity shall be tested in accordance with the provisions of GB/T 16886.5.
5.5 Dimensions
The dimensions shall be measured with general measuring tools or special measuring tools, and the number of samples shall not be less than 3 pieces.
5.6 Coordination performance
The test shall be carried out by imitating the working situation, and the number of samples shall not be less than 3 pieces.
6 Manufacturing
It shall comply with the provisions of YY/T 0640.
7 Sterilization
It shall comply with the provisions of YY/T 0640.
8 Packaging
It shall comply with the provisions of YY/T 0640.
9 Information provided by the manufacturer
9.1 Labeling
It shall comply with the provisions of YY/T 0640.
9.2 Marking
It shall comply with the provisions of YY/T 0640.
Appendix A
(Informative)
List of approved method standards for chemical analysis, metallographic examination
GB/T 5168 Microstructure and macrostructure examination for titanium and titanium alloys
GB/T 6394 Determination of estimating the average grain size of metal
GB/T 10561 Steel - Determination of content of nonmetallic inclusions - Micrographic method using standards diagrams
GB/T 13298 Inspection methods of microstructure for metals
GB/T 223 (all parts) Iron, steel and alloy
GB/T 4698 (all parts) Methods for chemical analysis of titanium sponge, titanium and titanium alloys
ASTM E1479 Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
ASTM E2371 Standard Test Method for Analysis of Titanium and Titanium Alloys by Direct Current Plasma and Inductively Coupled Plasma Atomic Emission Spectrometry (Performance-Based Test Methodology)
ASTM E1019 Standard Test Methods for Determination of Carbon, Sulfur, Nitrogen, and Oxygen in Steel, Iron, Nickel, and Cobalt Alloys by Various Combustion and Inert Gas Fusion Techniques
ASTM E1447 Standard Test Method for Determination of Hydrogen in Titanium and Titanium Alloys by Inert Gas Fusion Thermal Conductivity/Infrared Detection Method ASTM E1409 Standard Test Method for Determination of Oxygen and Nitrogen in Titanium and Titanium Alloys by Inert Gas Fusion
ASTM E45 Standard Test Methods for Determining the Inclusion Content of Steel ASTM E112 Standard Test Methods for Determining Average Grain Size
ETTC2:1979 Microstructural standards for titanium alloy bars
Appendix C
(Normative)
Measuring method of the axial insert strength of a femur neck screw
C.1 Overview
This test method specifies the test method for measuring the axial insert strength of the femur neck screw. The femur neck screw is installed in the loading device, and the testing machine applies a compressive load to fully insert the working part of the femur neck screw (as shown in Figure C.1) into the test block; the maximum pressure is the axial insert strength.
The purpose of this test method is to provide a test method for measuring the axial insert strength of femur neck screws, so as to compare femur neck screws of different types, materials, designs, processes, and surface treatments. The result obtained by this test method is not equivalent to the force value required by the femur neck screw when it is knocked into the human body.
C.2 Test device
The test device used to determine the axial insert strength of the femur neck screw is shown in Figure C.2. The test device shall include a test block made of materials conforming to ASTM F1839, a fixture, and a loading device. At the same time, the test block fixture and loading device shall have sufficient stiffness so that the deformation under the required loading conditions can be ignored.
a) Test block
The test block shall preferably be made of polyurethane foam conforming to ASTM F1839. The upper and lower surfaces of the test block shall be flat, smooth, and parallel to each other (the deviation shall be within the range of ±0.4 mm) to ensure that when it is fixed in the fixture, its upper surface is perpendicular to the centerline of the femur neck screw. The test block shall be square or other shapes that can ensure that there is no relative movement and deformation of the test block during clamping or testing. The thickness of the test block shall be at least 10 mm greater than the length of the working part of the femur neck screw, and the distance from the edge of the insertion position to the edge of the test block shall be at least 1.5 times the diameter of the femur neck screw.
b) Loading device
It is a device used to apply a compressive load to the femur neck screw, the load Appendix D
(Normative)
Test methods of static compression bending performance and fatigue
compression bending performance of femur neck screws
D.1 Overview
The femur neck is located at the proximal end of the femur, which bears the weight of the upper body of the human body, transmits the elements of human mechanics from top to bottom, and maintains the biomechanical functions of the lower limbs. The femur neck screws implanted in the femur neck are subjected to compressive bending loads in the human body, which is the most common type of loading in the human body. The purpose of this test method is to provide a test method for measuring the compression bending performance of femur neck screws, which can be used for comparison between femur neck screws of different types, materials, designs, processes, and surface treatments, so as to provide more useful information for the evaluation on the safety and practicality of the products. The results are not suitable as the basis for predicting the use of the product in the human body.
D.2 Test methods and procedures for the static compression bending performance of femur neck screws
D.2.1 Rigidly fix the head end of the femur neck screw on the testing machine, as shown in Figure D.1. The fixed end shall be strong enough and shall not be loose during the test. In principle, the loading moment arm L shall not be lower than 1/2 of the full length of the femur neck screw. The femur neck screw forms an angle α with the horizontal direction (in general, α is recommended to be 45°±1°), and a vertical downward load is applied to the tail end of the femur neck screw. The loading device shall be able to eliminate the side load during the compression bending process.
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