HOME   Cart(0)   Quotation   About-Us Tax PDFs Standard-List Powered by Google www.ChineseStandard.net Database: 189760 (2 Nov 2024)

YY/T 0346-2022 Related PDF English (YY0346-2002)

YY/T 0346-2022 (YY/T0346-2022, YYT 0346-2022, YYT0346-2022) & related versions
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusSimilar PDF
YY/T 0346-2022English245 Add to Cart 0-9 seconds. Auto delivery. Implants for osteosynthesis - Metallic fixation screw for femur neck YY/T 0346-2022 Valid YYT 0346-2022
YY 0346-2002English439 Add to Cart 3 days Implants for osteosynthesis. Metal nail of neck fixation of femur YY 0346-2002 Obsolete YY 0346-2002
Buy with any currencies (Euro, JPY, KRW...): YY/T 0346-2022    Preview this PDF: YY/T 0346-2022



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. ......

BASIC DATA
Standard ID YY/T 0346-2022 (YY/T0346-2022)
Description (Translated English) Implants for osteosynthesis - Metallic fixation screw for femur neck
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 16,110
Date of Issue 2022-05-18
Date of Implementation 2023-06-01
Older Standard (superseded by this standard) YY 0346-2002
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China) Co., Ltd., Suzhou MicroPort Spinal Trauma Medical Technology Co., Ltd., Dabo Medical Technology Co., Ltd., Stryker (Beijing) Medical Devices Co., Ltd., Johnson & Johnson ( Shanghai) Medical Equipment Co., Ltd.
Administrative Organization Orthopedic Implants Subcommittee of National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC 110/SC 1)
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the terms and definitions, requirements, test methods, manufacture, sterilization, packaging and information provided by the manufacturer of metal femoral neck nails (hereinafter referred to as femoral neck nails). This standard applies to femoral neck nails, which are used for internal fixation of femoral neck fractures during orthopedic surgery.

BASIC DATA
Standard ID YY 0346-2002 (YY0346-2002)
Description (Translated English) Implants for osteosynthesis. Metal nail of neck fixation of femur
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 11,112
Date of Issue 2002-09-24
Date of Implementation 2003-04-01
Quoted Standard GB/T 191; GB/T 4234; GB/T 4340; GB/T 13810; YY 0018; YY/T 1074; YY 0341
Drafting Organization Medical Devices Co., Ltd., Jiangsu Jinlu Group
Administrative Organization National standardization technical committee of Surgical characters and orthopedic implant device
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the fixed metal femoral nail classification, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to stationary metal femoral nail (hereinafter referred to as the femoral neck screw), the product for orthopedic surgery for femoral neck fracture fixation with.