YY/T 0346-2022 (YY/T0346-2022, YYT 0346-2022, YYT0346-2022)
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Implants for osteosynthesis - Metallic fixation screw for femur neck
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YY/T 0346-2022
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| YY 0346-2002 | English | 439 |
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Implants for osteosynthesis. Metal nail of neck fixation of femur
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YY 0346-2002
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| 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Count Estimation | 16,110 | | Date of Issue | 2022-05-18 | | Date of Implementation | 2023-06-01 | | Older Standard (superseded by this standard) | YY 0346-2002 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China)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. |
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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