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
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 Appen...