YY/T 0119.1-2014Spinal implants—Components used in the surgical fixation of the spinal skeletal system - Part 1: General requirements (English PDF)

1 Scope

This Part of YY/T 0119 specifies the general terms used to describe the dimensions and other physical characteristics of the components used in the surgical fixation of the spinal skeletal system. It also specifies the requirements for materials, manufacturing, sterilization, packaging, and information provided by the manufacturer for the components used in the surgical fixation of the spinal skeletal system.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB 4234, Stainless steel for surgical implants

GB/T 10623, Metallic material - Mechanical testing - Vocabulary

GB/T 13810, Wrought titanium and titanium alloy for surgical implants

GB/T 16825.1, Verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Verification and calibration of the force-measuring system

GB 23102, Implants for surgery - Metallic materials - Wrought titanium - 6aluminium-7niobium alloy

YY/T 0119.2-2014, Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 2: Metallic spinal screws

YY/T 0119.3-2014, Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 3: Metallic spinal plates

YY/T 0119.4-2014, Spinal implants - Components used in the surgical fixation of the spinal skeletal system - Part 4: Metallic spinal rods

YY/T 0640-2008, Non-active surgical implants - General requirements

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

YY/T 0961, Standard guide for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants

ISO 5832-2, Implants for surgery - Metallic materials -Part 2: Unalloyed titanium)

ISO 5832-3, Implants for surgery - Metallic materials - Part 3: Wrought titanium6-aluminium4-vanadiumalloy

ASTM F 382, Specification and Test Method for Metallic Bone Plates

ASTM F 543, Specification and Test Methods for Metallic Medical Bone Screws ASTM F 1582, Terminology Relating to Spinal Implants

3 Terms and definitions

For the purposes of this document, the terms and definitions defined in GB/T 10623, YY/T 0857, YY/T 0961, ASTM F 382, ASTM F 543, ASTM F 1582 as well as the followings apply.

4 Meaning and application

4.1 The spinal implant system usually consists of several components. Screws, plates, and rods are part of many spinal implant structures. These components are designed to transfer loads between the bones and the longitudinal and/or transverse elements. This Part makes provisions for these components and defines standard equivalent test methods for evaluating different types of components.

4.2 The loading method of the spinal component in the body may be different from the loading method of the loading device explained in this Part, therefore, the results obtained when using this Part of the test may not be able to predict the in vivo performance of the component or structure as a whole. However, these tests can be used to compare the mechanical properties of different types of components.

4.3 The mechanical characteristics related to the performance of the spinal components measured in this Part can be used to predict the mechanical properties of components with similar functions and indications but with different types.

5 Materials

5.1 The manufacturer is responsible for ensuring that the materials used to manufacture the spinal components are suitable for implantation in the human body. The applicability of the material can be verified in accordance with the method of YY/T 0640.

5.2 When choosing a material, the manufacturer shall also consider the materials of other components in the spinal implant structure. When mixing different materials in the structure of spinal implants, unacceptable corrosion shall be prevented.

5.3 Some materials that have been used as spinal components are given below:

- Pure titanium (ISO 5832-2);

- Ti-6Al-4V alloy (ISO 5832-3);

- Stainless steel (see GB 4234);

Annex A (informative) Basic principle

A.1 This Part aims to provide practical and unified information related to the application of terminology, performance, test methods and the application of spinal structural components. This Part provides the geometric definition, size, classification and terminology, material and performance definitions of spine structural components.

A.2 Surgeons shall have the ability to select spinal instruments suitable for the indications of the patients. To achieve this goal, doctors shall make sure that the size of the implant and the naming of its supporting tools have specific and recognized meanings. Regardless of the manufacturer or type, these names are quantifiable and reliable. Regardless of the manufacturer or type, the mechanics and material properties shall also be described in a reliable and recognized way. In order to ensure the consistency of naming, the terminology, size, mechanics and material properties used shall be standardized.

A.3 Since the current level of knowledge is not enough to predict the effect of specific spinal implant types and assembly components, this Part is not used to define the performance level of spinal implants.