YY/T 1782-2021Test methods for mechanical property of external skeletal fixation devices (English PDF)
骨科外固定支架力学性能测试方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 6, 2021
Implementation date
September 1, 2022
Scope
YY/T 1782-2021 is the English-translated version of 骨科外固定支架力学性能测试方法.
YY/T 1782-2021 is the Chinese pharmaceutical industry standard that gives six test methods for the mechanical properties of external skeletal fixation devices, the frames held outside the limb by pins and wires.
It applies to subassemblies and to single assemblies of such a frame, and sets out for each method the specimen, the mounting, the loading and the quantities derived from it, such as stiffness and strength under compression, bending and torsion.
The user chooses the methods that suit the design in hand rather than running them all. Issued on 6 September 2021, it has applied since 1 September 2022.
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Document preview — YY/T 1782-2021
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Significance and application
- 5 Test method
- Appendix A (Normative Appendix) Test Methods for External Fixation Bracket Connectors
- Appendix B (Normative Appendix) Test Methods for Determining In-Plane Compression Performance of Full Ring or Half Ring Bridge Components
- Appendix C (Normative Appendix) Test Method for External Fixation Bracket Connection
- Appendix D (Normative Appendix) Test Methods for External Fixation Bone Pins
- Appendix E (Normative Appendix) Test Methods for External Fixation Bracket Subassemblies
- Appendix F (Normative Appendix) Test Method for External Fixation Structural System
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies six test methods for the mechanical properties of orthopaedic external fixation brackets.
This standard applies to component subassemblies or single assemblies of orthopaedic external fixation brackets.
Note. This standard contains a variety of test methods, however, users do not need to use all the methods in this standard to test. Users should use reasonable Select the test method suitable for a specific design device, which can be a subset of the test methods in this standard.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 10623 Terminology for Mechanical Properties Test of Metal Materials
GB/T 16825.1 Inspection of static uniaxial testing machines Part 1: Inspection and calibration
GB/T 24176 Statistical scheme and analysis method of fatigue test data for metallic materials
YY/T 0591-2011 Metal interlocking intramedullary nail for bone engaging implants
3 Terms and Definitions
The terms and definitions defined in GB/T 10623 and the following apply to this document.
3.1 A modular instrument assembled from subassemblies, widely used in orthopaedic
surgery, especially in fracture fixation and/or limb lengthening superior. Its sub-assemblies usually include. anchoring components (usually percutaneous); bridging components (usually extracutaneous); connecting components, etc.
3.2 External fixator-boneconstruct
The structure of the assembled external fixator and bone or bone substitute. The structure can be based on the anatomy of the bone to which the external fixator is applied. structure to classify.
Example. Common types are long bones, joints, pelvis, spine, skull, etc.
3.4 Component
The individual components (or modules of components) used by the user to assemble the external fixation bracket.
3.5 Mechanical defect
Discontinuities of the bone, the external fixator usually spans the discontinuity of the patient's bone, otherwise it cannot be in one or more parts.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 48 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 10623Metallic material -- Mechanical testing -- Vocabulary
- GB/T 16825.1Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Calibration and verification of the force-measuring system
- GB/T 24176Metallic materials -- Fatigue testing -- Statistical planning and analysis of data
- YY/T 0591-2011Implants for osteosynthesis - Metallic lockable intramedullary nails
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Related Standards
GB/T 10623-2008 — Metallic material -- Mechanical testing -- Vocabulary
GB/T 16825.1-2022 — Metallic materials - Calibration and verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Calibration and verification of the force-measuring system
GB/T 24176-2009 — Metallic materials -- Fatigue testing -- Statistical planning and analysis of data
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