YY/T 0591-2011
Implants for orthosynthesis.Metallic lockable intramedullary nail (English Version)

Standard No.

YY/T 0591-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

Professional Standard - Medicine

Latest

YY/T 0591-2011

Replace

YY 0591-2005

Scope

This standard specifies the design characteristics and mechanical properties of metal lockable intramedullary nails (hereinafter referred to as locking intramedullary nails), and specifies basic geometric definitions, dimensions, classification, terminology, materials, surface treatment, sterilization , packaging, and requirements for information provided by manufacturers, provide test methods for characterizing the mechanical properties of locking intramedullary nails, and identify the need for continued improvement of test methods and performance standards. The ultimate purpose of this standard is to define the performance standards and test methods for performance-related mechanical properties and bone fixation of locking intramedullary nails. Because insufficient knowledge is not available, it is not possible to predict the outcome of the use of locked intramedullary nails in individual patients for specific activities of daily living. The purpose of this standard is not to define the performance level or clinical performance of locking intramedullary nails in specific cases, nor does this standard describe or regulate the specific design of locking intramedullary nails. This standard describes locking intramedullary nails for surgical fixation of the skeletal system. Provides basic geometric definitions, dimensions, classification and terminology, labeling and material standards, performance definitions, and testing and characterization methods of important properties of locking intramedullary nails in vivo and related to use. This standard includes 4 standard test methods: 　——Static four-point bending test method (Appendix A); 　——Static torsion test method of locking intramedullary nails (Appendix B); 　——Bending fatigue test of locking intramedullary nails Method (Appendix C); 　——Bending fatigue test method of locking intramedullary nail locking screws (Appendix D). The rationale is given in Appendix E. This standard uses the International System of Units (SI).

YY/T 0591-2011 Referenced Document

• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-19 Update
• GB 23102 Implants for surgery.Metallic materials-Wrought titanium-6aluminium-7niobium alloy
• GB 4234 Stainless steel for surgical implants
• GB/T 10623 Metallic material.Mechanical testing.Vocabulary
• GB/T 12417.1 Non-active surgical implants.Osteosynthesis and joint replacement implants.Part 1:Particular requirements for osteosynthesis implants
• ISO 5832-3 Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy*， 2021-11-18 Update
• JJG 139 multibeam echo sounder for shallow water
• YY 0605.9 Implants for surgery.Metallic materials.Part 9:Wrought high nitrogen stainless steel*， 2015-03-02 Update
• YY/T 0640-2008 Non-active surgical implants-General requirements
• YY/T 0727.1 Implants for surgery.Metal intramedullary nailing system.Part 1:Intramedullary nails
• YY/T 0727.2 Implants for surgery.Metal intramedullary nailing system.Part 2:Locking components
• YY/T 0727.3 Implants for surgery.Metal intramedullary nailing system.Part 3:Connection devices and reamer diameter measurements

YY/T 0591-2011 history

• 2011 YY/T 0591-2011 Implants for orthosynthesis.Metallic lockable intramedullary nail
• 2006 YY 0591-2005 Bone juncture implants metal intramedullary interlocking nail

YY/T 0591-2011 Implants for orthosynthesis.Metallic lockable intramedullary nail has been changed from YY 0591-2005 Bone juncture implants metal intramedullary interlocking nail.