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YY/T 0119.1-2014 English PDF (YYT0119.1-2014)

YY/T 0119.1-2014 English PDF (YYT0119.1-2014)

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YY/T 0119.1-2014: Spinal implants. Components used in the surgical fixation of the spinal skeletal system. Part 1: General requirements

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.
YY/T 0119.1-2014
GB
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.40
C 35
Partly replacing YY 0119-2002, YY 0120-2002
Spinal implants - Components used in the surgical
fixation of the spinal skeletal system - Part 1: General
requirements
ISSUED ON: JUNE 17, 2014
IMPLEMENTED ON: JULY 01, 2015
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 7
4 Meaning and application ... 13
5 Materials ... 13
6 Requirements ... 14
7 Manufacture ... 14
8 Sterilization ... 14
9 Packaging ... 14
10 Information provided by the manufacturer ... 14
Annex A (informative) Basic principle ... 16
Annex B (informative) List of approved method standards for chemical analysis ... 18
Bibliography ... 19
Spinal implants - Components used in the surgical
fixation of the spinal skeletal system - Part 1: General
requirements
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.
3.1 expansion head screw
a threaded anchor that the head can be elastically deformed, and it is
mechanically connected to other spine structural elements.
3.2 locking screw
a threaded anchor that is rigidly connected to longitudinal elements in spinal structure.
3.3 self-locking screw
a threaded anchor that deforms at the end of the screwing process and locks with the mating spine structural element.
3.4 shaft screw
a threaded anchor of which the thread diameter is equal to the diameter of its non-threaded rod.
3.14 exposed length
the linear distance between the surface of the test block where the screw is embedded and the screw anchoring position (usually the axis of the longitudinal element) on the test fixture (see Figure 5).
NOTE: It is expressed in millimeters (mm).
3.15 gross failure
the offset displacement caused by fracture or plastic deformation that exceeds the yield displacement and can lead to failure of spinal components.
3.16 insertion depth
the linear distance between the position of the screw in the test block and the position on the outer surface of the test block before the test.
NOTE: It is expressed in millimeters (mm).
3.17 median bending fatigue moment at N cycles
under the specified R ratio, 50% of the specimens in a given sample can be expected to withstand the maximum bending moment of N loading cycles.
NOTE: It is expressed in newton meters (N??m).
3.18 permanent displacement
when the load is removed, the total displacement remaining on the test sample. 3.19 torsion yield moment
the torque applied when the screw reaches its proportional limit.
NOTE 1: This value is measured by the offset method, and the offset angle is 2??. NOTE 2: It is expressed in newton meters (N??m).
3.20 total displacement
the distance moved by the loading point in the loading direction relative to the zero-load intercept of the initial linear part of the load-displacement curve (see point O in Figure 4).
NOTE: It is expressed in millimeters (mm).
3.21 yield displacement
the total displacement corresponding to the bending yield strength (such as the distance OA in Figure 4).
NOTE: It is expressed in millimeters (mm).
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.
A.4 This Part includes test methods for evaluating static and dynamic
mechanical properties of spinal components used as anchoring elements or longitudinal elements in spinal structures. Spinal implants are used to provide short-term stable fixation during arthrodesis. This Part does not involve long- term mechanical problems of spinal components, nor does it involve the
performance of non-fusion spinal implants.
A.5 One of the purposes of this Part is to provide a consistent standard test method, used to evaluate the fatigue strength of spine components under meaningful cycles. It is generally believed that the average time for bone fusion is about 12 months. During this period, the implant undergoes approximately 1??106 to 2.5??106 cycles in the body. If the number of cycles is doubled from 2.5??106 times to 5??106 times, the safety factor can be improved. But in fact, it only increases the cost of testing and does not provide more meaningful data. Even if the failure occurs in the 2.5??106~5??106 cycle interval, it usually occurs below the horizontal part of the curve and will not significantly affect the curve itself. Therefore, 2.5??106 times is used as the cycle termination limit. A.6 Simulated body fluids or saline may affect the relative performance of the

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