YY 0341.2-2020 in English

Non-active surgical implants - Osteosynthesis and spinal implants - Part 2: Particular requirements for spinal implants

1 Scope

This part of YY 0341 specifies the particular requirements for non-active surgical spinal implants (hereinafter referred to as "spinal implants"). In addition to the requirements specified in YY/T 0640, it also specifies the definition, requirements, test methods, manufacturing, sterilization, packaging and information to be supplied by the manufacturer of spinal implants.

This part of YY 0341 is applicable to non-active surgical spinal implant except artificial intervertebral disc implants.

2 Normative references

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

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
YY/T 1074 Implants for surgery - Measuring method for pitting corrosion potential on stainless products
YY/T 1428 Spinal implants - Relevant terms
YY/T 1615 Surgical implants - Anodizing oxide layers on titanium and titanium alloys - General requirements
YY/T 1706.1 Implants for surgery - Plasma-sprayed unalloyed titanium coatings on metallic surgical implants - Part 1: General requirements


3 Terms and definitions

For the purposes of this document, the terms and definitions given in YY/T 0640-2016 and YY/T 1428 and the following apply.

3.1
non-active surgical spinal implant
non-active surgical implant products used to provide support or deformity correction for spine

3.2
coating
layer of material used to cover or partially cover the surface of an implant

3.3
anodizing titanium and titanium alloy
electrochemical oxidation of titanium and titanium alloy, i.e. the process of forming an oxide layer on the surface under specific process conditions with titanium and titanium alloy as anodes under the action of an external electric field in corresponding electrolyte

4 Requirements

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Manufacturing
7 Sterilization
8 Packaging
9 Information to be supplied by the manufacturer
Annex A (Informative) Relevant standards for clinically proven acceptable materials
Annex B (Informative) List of approved standards for chemical analysis methods
Annex C (Informative) Relevant standards for design evaluation and test