YY 0341.2-2020Non-active surgical implants—Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants (English PDF)

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 Ralpha value of the main surface of the spinal implant.

If there are relevant product standards, the roughness Ralpha 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.

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 […]