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

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY/T 0346-2022 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0346-2022
Preview True-PDF (Reload/Scroll-down if blank)

YY/T 0346-2022: Implants for osteosynthesis - Metallic fixation screw for femur neck
YY/T 0346-2022
Implants for osteosynthesis - Metallic fixation screw for femur neck
ICS 11.040.40
CCSC35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0346-2002
Osseointegration Implant Metal Femoral Neck Fixation Nail
Published on 2022-05-18
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 2
5 Test method 3
6 Manufacturing 5
7 Sterilization5
8 pack 5
9 Information provided by the manufacturer5
Appendix A (Informative) List of Approved Methods and Standards for Chemical Analysis and Metallographic Inspection 6
Appendix B (normative) Description of maximum torque and method of determination of torsion angle at break 7
Appendix C (Normative) Method for Determination of Axial Insertion Force of Femoral Neck Nails 8
Appendix D (Normative) Test Methods for Static Compression-Bending and Fatigue Compression-Bending Performance of Femoral Neck Nails 10
Reference 13
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document replaces YY 0346-2002 "Metallic Femoral Neck Fixation Nails for Bone Joint Implants". Compared with YY 0346-2002, except for editing
The main technical changes other than editorial revisions are as follows.
--- Delete the classification (see Chapter 3 of the.2002 edition);
--- Added terms and definitions (see Chapter 3);
--- "Requirements" have added applicable standards for materials (see 4.1), increased torsional performance (see 4.2.1), axial insertion force (see 4.2.3),
Axial pull-out force (see 4.2.4), screw-in torque and screw-out torque (see 4.2.5), self-tapping performance (see 4.2.6), static bending performance (see 4.2.6)
4.2.7), fatigue bending performance (see 4.2.8), delete the numerical requirements of surface roughness (see 4.4.2 of the.2002 edition),
Added anodized surface treatment (see 4.4.4);
--- Added test methods for new items (see 5.2.1, 5.2.3, 5.2.4, 5.2.5, 5.2.6, 5.2.7, 5.2.8, 5.4.4);
--- Delete the inspection rules (see Chapter 6 of the.2002 edition);
--- Increased requirements for manufacturing (see Chapter 6);
--- Increased the requirements for sterilization (see Chapter 7);
--- Added requirements for labels (see 9.1);
--- Added Appendix A~Appendix D.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is approved by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices Orthopedic Implants Subcommittee (SAC/TC110/SC1)
focal point.
This document is drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Trauson Medical Devices (China) Co., Ltd., Suzhou MicroPort
Column Trauma Medical Technology Co., Ltd., Dabo Medical Technology Co., Ltd., Stryker (Beijing) Medical Equipment Co., Ltd., Johnson and Johnson (Shanghai)
Medical Equipment Co., Ltd.
The main drafters of this document. Jing Ming, Ma Chunbao, Zhang Shu, Wang Tao, Cui Hong, Chen Changsheng, Wang Jian, Yu Tianbai, Li Xuan, Zeng Da, Zhang Erlai,
Zhang Haiming, Zhang Songwei, Wang Rongfei, Gao Xiangfei.
The previous versions of the documents replaced by this document are as follows.
---YY 0346-2002.
Osseointegration Implant Metal Femoral Neck Fixation Nail
1 Scope
This document specifies the terms and definitions, requirements, test methods, manufacture, sterilization,
packaging and information provided by the manufacturer.
This document applies to femoral neck nails, which are used for internal fixation of femoral neck fractures during orthopedic surgery.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB 4234.1 Surgical Implant Metallic Materials Part 1.Forged Stainless Steel
GB/T 4340.1 Vickers Hardness Test for Metal Materials Part 1.Test Methods
GB/T 10610 Product Geometric Specifications (GPS) Rules and Methods for Evaluating Surface Structure by Surface Structure Profile Method
GB/T 13810 Titanium and titanium alloy processing materials for surgical implants
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test
GB 23102 Surgical implant metal material Ti-6Al-7Nb alloy processing material
YY 0018 Bone engaging implant metal bone screw
YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants
YY 0605.9 Surgical Implant Metallic Materials Part 9.Forged High Nitrogen Stainless Steel
YY/T 0640 General requirements for passive surgical implants
YY/T 0662 Mechanical performance requirements and test methods for metal bone screws with asymmetric threads and spherical lower surfaces of surgical implants
YY/T 0856 Bone-joint implant metal angle fixator
YY/T 1074 Pitting corrosion potential of stainless steel products for surgical implants
YY/T 1504 Test method for axial pull-out force of metal bone screws for surgical implants
YY/T 1505 Test method for self-tapping performance of metal bone screws for surgical implants
YY/T 1506 Test method for rotational torque of metal bone screws for surgical implants
3 Terms and Definitions
The terms and definitions defined in YY 0018, YY/T 0856 and the following apply to this document.
3.1
Made of metal materials, used alone or with other implants (such as angle fixators, intramedullary nails, bone plates, etc.) during femoral neck fracture surgery
Combined use, implants placed in the neck of the femur.
3.2
axialinsertstrength
The working part of the femoral neck screw (see Figure C.1 in Appendix C), which is implanted in the human body by tapping, is completely inserted into the test block.