YY/T 1598-2018Tissue engineering medical device products—Bone:Standard guide for bone repairing or regenerative evaluation of implant for spinal fusion (English PDF)
组织工程医疗器械产品 骨 用于脊柱融合的外科植入物的骨修复或再生评价试验指南
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Issued by
China Food and Drug Administration
Level / Type
Industry · Recommended
Issue date
April 11, 2018
Implementation date
May 1, 2019
Scope
YY/T 1598-2018 is the English-translated version of 组织工程医疗器械产品 骨 用于脊柱融合的外科植入物的骨修复或再生评价试验指南.
YY/T 1598-2018 is the Chinese standard "Tissue engineering medical device products—Bone:Standard guide for bone repairing or regenerative evaluation of implant for spinal fusion".
Its scope clause reads: This standard provides guidelines for in vivo bone repair or regeneration evaluation of implants for spinal fusion prior to clinical application.
This standard applies to surgical implants for tissue fusion medical device products for spinal fusion. Note 1. The model described in this standard will rigorously test the ability of materials to induce and/or enhance bone growth in and around the spinal intervertebral space.
Note 2. Although tissue engineering medical device products may be clinically used in combination with internal or external fixation devices, this standard focuses on animal model selection.
Appropriateness and evaluation of the repair, but not the problem of the combined device. Its clauses include terms and definitions.
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Document preview — YY/T 1598-2018
National Standard of the People's Republic of China
- ICS
- 11.040.40
- Classification
- C 45
Issued by: China Food and Drug Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 3.
1 Scope
This standard provides guidelines for in vivo bone repair or regeneration evaluation of implants for spinal fusion prior to clinical application.
This standard applies to surgical implants for tissue fusion medical device products for spinal fusion.
Note 1. The model described in this standard will rigorously test the ability of materials to induce and/or enhance bone growth in and around the spinal intervertebral space.
Note 2. Although tissue engineering medical device products may be clinically used in combination with internal or external fixation devices, this standard focuses on animal model selection.
Appropriateness and evaluation of the repair, but not the problem of the combined device.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Bone regeneration
A process of forming tissue having a structure and function similar to normal bone tissue.
3.2 Bone reconstruction Boneremodeling
A process that occurs throughout life, where old bones are removed from the bones (called bone resorption) and new bones are added (called bone formation).
Note. These processes are accompanied by bone growth processes and remodeling or replacement after injury. Reconstruction corresponds to functional requirements and muscle attachment. Therefore, bone
Replenished where needed and cleared where it is not needed.
3.3 Bone repair
The healing process of damaged bone or its substitute through cell proliferation and synthesis of new extracellular matrix.
3.4 Interbody fusion in the spine
A method of obtaining a fusion of the bone by placing a bone graft between adjacent vertebrae, usually placed in the area occupied by the intervertebral disc method.
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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
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
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