YY/T 1502-2016Spinal implants—Intervertebral body fusion devices (English PDF)
脊柱植入物椎间融合器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 1502-2016 is the English-translated version of 脊柱植入物椎间融合器.
YY/T 1502-2016 is the Chinese pharmaceutical industry standard for the intervertebral body fusion device, the cage placed between two vertebral bodies to hold them apart while they fuse.
It specifies the terms and definitions, the intended performance, the design attributes, the materials, the preclinical evaluation, the manufacture, the sterilization, the packaging and the information the manufacturer provides, covering the static and fatigue strength of the device, the subsidence and the expulsion, and the surface and the materials of which it is made. Issued on 29 July 2016, it has applied since 1 June 2017.
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Document preview — YY/T 1502-2016
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions of intervertebral fusion, expected performance, design attributes, materials, preclinical evaluation, manufacturing, sterilization, packaging And the information provided by the manufacturer.
This standard is applicable to intervertebral fusion devices that are placed in the intervertebral disc position and provide support for the fusion of the two vertebral bodies.
This standard applies to intermolecular fusion devices made of metal and polymeric materials and is not suitable for use in pharmaceutical combinations (eg, White interbody fusion cage).
2 Normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.
Metallic materials - Vickers hardness test - Part 1. Test methods GB/T
GB/T 10610 Geometrical product specifications (GPS) - Surface texture contour method - Rules and methods for assessing surface structures
GB/T 13810 Surgical implants for titanium and titanium alloys Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.5
GB 23102 surgical implants metal materials Ti-6Al-7Nb alloy processing materials
YY/T 0343 Surgical metal implants - Liquid penetration test Test method for X - ray impermeability of medical polymer products YY/T 0586 General requirements for passive surgical implants YY/T 0640-2008 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implants YY/T 0660 Test Method for Mechanical Properties of Lumbar Implant Interbody Fusion Instrument YY/T 0959 Standard Test Method for Static Axial Compressive Subsidence of Lumbar Implant Interbody Fusion Instrument YY/T 0960
YY/T 0966 Surgical Implants Metal Materials Pure Tantalum
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Interbody fusion intervertebralbody
A (biological or artificial) instrument that is mounted on the intervertebral disc between two segments of the intervertebral body. The purpose is for the end of two adjacent vertebral bodies Integration to provide support. [YY/T 0959-2014, definition 3.7]
3.2 Vertebral sinking
Has been implanted in the intervertebral fusion device around the vertebral body defect or subsidence process, the process will lead to disc height loss. [YY/T 0960-2014, definition 3.5]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- GB 23102Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
- YY/T 0343Liquid penetrant inspection of metallic surgical implants
- YY/T 0966Implants for surgery - Metallic materials - Unalloyed tantalum
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Related Standards
GB 23102-2008 — Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
GB/T 13810-2017 — Wrought titanium and titanium alloys for surgical implants
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YY/T 1502-2016
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