YY/T 0857-2011 (English Version) PDF

Scope: This standard specifies materials and methods for static and fatigue testing of spinal implant components in corpectomy models. The materials tested for most spinal implant component combinations depend on the intended spinal implant site and method of application. These test methods are intended to provide a basis for comparison of the mechanical properties of past, present, and future spinal implant components, allowing comparison of spinal implant constructs that differ in their intended site of application and method of application. These test methods are not intended to define performance levels because there is insufficient information to predict the results of using a given implant. These test methods provide guidance on loading types and loading methods, specifying three static test methods and one fatigue test method for the comparative evaluation of spinal implant components. These test methods establish principles for measuring displacement, determining yield load, and evaluating the stiffness and strength of spinal implant components. Some structures may not be tested in all test models. This standard uses the International System of Units. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the users of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory limitations prior to application.

YY/T 0857-2011 Referenced Document

ASTM E739 Standard Practice for Statistical Analysis of Linear or Linearized Stress-Life (S-N) and Strain-Life (949;-N) Fatigue Data
ASTM F1582 Standard Terminology Relating to Spinal Implants
ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices*， 2022-07-01 Update
GB/T 10623 Metallic material.Mechanical testing.Vocabulary
GB/T 19701.2 Implants for surgery.Ultra-high-molecular-weight polyethylene.Part 2: Moulded forms*， 2016-12-13 Update
JJG 139 multibeam echo sounder for shallow water

2011 YY/T 0857-2011 Standard test methods for spinal implant constructs in a vertebrectomy model