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YY 0341.2-2020: Non-active surgical implants -- Osteosynthesis and spinal implants -- Part 2: Particular requirements for spinal implants
YY 0341.2-2020
YY
PHARMACEUTICALS INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0341-2009
Non-active surgical implants - Osteosynthesis and
spinal implants - Part 2: Particular requirements for
spinal implants
无源外科植入物 骨接合与脊柱植入物
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: JUNE 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Requirements ... 6 
5 Test method ... 8 
6 Manufacturing ... 11 
7 Sterilization ... 11 
8 Packaging ... 11 
9 Information provided by the manufacturer ... 11 
Appendix A (Informative) Relevant material standards acceptable for clinical
use ... 13 
Appendix B (Informative) List of approved method standards for chemical
analysis ... 15 
Appendix C (Informative) Relevant standards for design evaluation and testing
... 16 
Non-active surgical implants - Osteosynthesis and
spinal implants - Part 2: Particular requirements for
spinal implants
1 Scope
This Part of YY 0341 specifies the special requirements for non-active surgical
spinal implants (hereinafter referred to as "spinal implants"). In addition to the
requirements that are specified in YY/T 0640, it also specifies the definition,
requirements, test methods, manufacturing, sterilization, packaging and
information provided by the manufacturer of spinal implants.
This Part of YY 0341 applies to non-active surgical spinal implants other than
artificial intervertebral disc implants.
2 Normative references
The following documents are indispensable 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 4340.1, Metallic materials - Vickers hardness test - Part 1: Test method
GB/T 10610, Geometrical product specifications (GPS) - Surface texture:
Profile method - Rules and procedures for the assessment of surface texture
GB/T 14233.2, Test methods for infusion, transfusion, injection equipment
for medical use - Part 2: Biological test methods
GB/T 16886.7, Biological evaluation of medical devices - Part 7: Ethylene
oxide sterilization residuals
GB 23101.2, Implants for surgery - Hydroxyapatite - Part 2: Coatings of
hydroxyapatite
YY/T 0343, Liquid penetrant inspection of metallic surgical implants
YY/T 0640-2016, Non-active surgical implants - General requirements
Note: Some material standards for spinal implants that have been proven
acceptable through clinical applications can be found in the informative
list that is given in Appendix A.
4.2 Hardness
The hardness of metal spinal implants shall meet the requirements of the
corresponding product standards.
4.3 Static and/or dynamic mechanical properties
The manufacturer shall combine the characteristics of the spinal implant and its
clinical use to specify its static and/or dynamic mechanical properties. If there
are relevant product standards, the mechanical properties of spinal implants
shall meet the requirements of the corresponding standards. Due to the
different characteristics of spinal implants, the test standards may not yet exist
or the existing test standards may be modified as needed.
4.4 Corrosion resistance
The pitting potential (Eb) on the surface of the final product of the stainless-steel
spinal implant shall not be less than 800 mV.
4.5 Surface quality
4.5.1 Surface defects
The surface of the non-coated metal spinal implant shall not have any
discontinuity defects.
4.5.2 Surface roughness
The manufacturer shall specify the roughness Rα value of the main surface of
the spinal implant.
If there are relevant product standards, the roughness Rα value of spinal
implants shall meet the requirements of the corresponding standards.
4.5.3 Appearance
The surface of the spinal implant shall be free of defects that affect the function
of the implant, as well as inlays, final processing deposits or other contaminants.
Note: Defects that affect the function include oxide skin, knife marks, small
nicks, scratches, cracks, depressions, sharp edges (except for cutting
edges), burrs and other defects.
4.5.4 Anodized surface treatment
implants, as well as the physical and chemical properties of polymer materials,
are tested according to the method that is specified in the material standard or
the recommended method in Appendix B.
Note: If the final product cannot be sampled due to structure or size, samples
of the same batch of raw materials and the same manufacturing process
can also be used.
5.2 Hardness
It is performed according to the method of GB/T 4340.1.
Note: Other validated methods are also acceptable.
5.3 Static and/or dynamic mechanical properties
When using static and/or dynamic load tests to evaluate spinal implants,
existing inspection standards can be used (see Appendix C for related
information), or a custom test model that considers the characteristics of the
implant can be used; the quantity of the samples required for tests shall be
determined according to the selected test method standard.
Note 1: The test method can be selected according to different test levels.
Note 2: Preclinical evaluation shall consider the existing data of similar implants
or design characteristics.
Note 3: Tests can be performed on specific implants under specific loads and/or
specific environmental conditions to evaluate their performance.
5.4 Corrosion resistance
It is performed according to the method that is specified in YY/T 1074. The
number of samples shall be no less than 3.
Note: If the final product cannot be sampled due to structure or size, samples
of the same batch of raw materials and the same manufacturing process
can also be used.
5.5 Surface quality
5.5.1 Surface defects
It is performed according to the method that is specified in YY/T 0343. The
number of samples shall be no less than 3.
Note: Other validated methods are also acceptable.
5.9.1 The sterility test shall be carried out according to the method that is
specified in GB/T 14233.2.
Note: Other validated methods are also acceptable.
5.9.2 The residual amount of ethylene oxide shall be carried out according to
the method that is specified in GB/T 16886.7.
Note: Other validated methods are also acceptable.
6 Manufacturing
It shall meet the requirements of Chapter 8 in YY/T 0640-2016.
7 Sterilization
It shall meet the requirements of Chapter 9 in YY/T 0640-2016.
8 Packaging
It shall meet the requirements of Chapter 10 in YY/T 0640-2016.
9 Information provided by the manufacturer
9.1 General principles
Chapter 11 of YY/T 0640-2016 and the following specific terms apply.
9.2 Instruction manual
It shall comply with the provisions of 11.3 in YY/T 0640-2016; the manufacturer
should also provide the following information:
Restrictions on any modification after delivery of the implant: size, shape,
surface condition.
9.3 Marking
9.3.1 The 11.5, 11.6 in YY/T 0640-2016 or the following terms apply.
9.3.2 The spinal implant’s marking consists of material code, manufacturer
name code, production batch number, etc. The material code is as specified in
Table 1, or expressed by the element symbol of the substrate.
Note 1: Implants that cannot completely c...