YY/T 1995-2025Tissue engineered medical device products - Evaluation experiment of cellular biological effects of cartilage scaffolds (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document was prepared by the Medical Device Products Subcommittee of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices. Under the jurisdiction of the relevant authorities. This document was drafted by: China National Institutes for Food and Drug Control, Center for Medical Device Evaluation of the National Medical Products Administration, and Zhejiang University. School of Medicine, General Hospital of the Chinese People's Liberation Army, Sichuan University, Kangxi Biomedical (Shenzhen) Co., Ltd., Zhejiang Xingyue Biotechnology Co., Ltd. Company, Huaxia Siyin (Shanghai) Biotechnology Co., Ltd. The main drafters of this document are. Chen Liang, Guo Xiaolei, Ouyang Hongwei, Guo Quanyi, Lin Hai, Li Jianmo, Zhao Hongshi, Chen Liyuan, and Chen Huimin.

Tissue-engineered cartilage scaffolds can be made from single or multiple natural biomaterials such as collagen, polylactic acid, and inorganic calcium salts, as well as synthetic polymers and inorganic materials. Composed of biomaterials, it can be made into various forms such as porous scaffolds and injectable gels. The role of cartilage scaffolds in cell function is the biological basis for their cartilage repair function. The effectiveness of these functions depends on the material of the cartilage scaffold. Properties, including but not limited to, material physicochemical properties, morphological properties, and surface topological properties. Currently, a large body of research has revealed the relationship between material properties and... The correlation between scaffold cartilage repair and cartilage repair has been studied, but no material property indicators that have been clinically proven to have a causal correlation with scaffold cartilage repair have yet been obtained. Furthermore, the material properties of cartilage scaffolds are complex and variable, and it is expected that necessary and sufficient characterization of cartilage scaffold materials will help predict product yield. The cell biological effects of life, thereby ensuring the cartilage repair effect based on cell action, have rationality and operability, etc. To be discussed. Therefore, this document proposes, based on material property characterization as a means of quality control for cartilage scaffolds, to explore the interaction between cartilage scaffolds and cells. Evaluation experiments were conducted to obtain the actual possible cellular biological effects of the cartilage scaffold. When the evaluated cellular biological effects involve the cartilage scaffold... When the mechanisms by which scaffolds repair cartilage are understood and quantitative evaluation data are available, it can provide more concrete evidence for cartilage repair effects based on cellular processes. Supporting evidence. However, identifying the cellular biological mechanisms underlying the causal relationship between cartilage scaffolds and cartilage repair is challenging and may even require clinical intervention. Feedback and verification of experimental results. Furthermore, considering the complex and variable material properties of cartilage scaffolds, the specific material properties selected are also considered. Based on the existing characteristics, combined with the evaluation of cartilage scaffold-cell interactions, further quality control of cartilage scaffolds can be provided. This document provides... This paper outlines the key factors to consider when designing these cell biology effect evaluation experiments, as well as recommended experimental methods. Cells of cartilage scaffolds in tissue-engineered medical devices Biological effect evaluation test

1 Scope

YY/T 1995 is the bench test that tells a cartilage scaffold maker whether their material actually supports cartilage cells. It specifies the in vitro test methods for detecting the proliferation, migration and differentiation of cells on a cartilage scaffold, the three behaviours that decide whether a tissue engineering scaffold does its job or merely occupies the defect. It belongs to the family of Chinese standards on tissue engineered medical device products, where scaffold evaluation has been built up standard by standard rather than in one document. For a manufacturer of cartilage repair scaffolds, this is the method a Chinese reviewer expects the cell biology data package to have followed, and it is the reference against which a foreign supplier's existing in vitro data will be compared when the product is submitted for registration in China.

This document specifies the experimental methods for in vitro detection of cell proliferation, migration, and differentiation on cartilage scaffolds. This document applies to the evaluation of the cellular biological effects of cartilage scaffolds.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.

YY/T 1562 Guidelines for Cell Viability Testing of Biomaterial Scaffolds in Tissue Engineering Medical Devices

YY/T 1744 Measurement Method for Cell Migration in Bioactive Ceramic Porous Materials for Tissue-Engineered Medical Devices

YY/T 1810 Quantitative detection of sulfated glycosaminoglycans (sGAGs) used to evaluate cartilage formation in tissue-engineered medical products

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 scaffold Supports, structural components, release vectors, or matrices composed of synthetic and/or naturally derived materials, used to modulate biological functions (including...) Including but not limited to adhesion, migration, proliferation, differentiation), or transport of exogenous and/or endogenous cells, and/or binding of bioactive factors. delivery. [Source: YY/T 0606.15-2023, 3.12]

3.2 Cartilage repair The healing process of damaged cartilage or its replacement material involves cell proliferation and the synthesis of new extracellular matrix. [Source: YY/T 1445-2016, 3.12]

4 Overview

4.1 When cartilage scaffolds exert their cartilage repair function, relying on the characteristics of the scaffold material to generate cell biological effects is an essential pathway. It is generally believed that the relevant cell biological effects mainly include cell migration, proliferation, and differentiation. When evaluating a specific cartilage scaffold, it is advisable to select... Appropriate cell biological effect assays may be required for evaluation; all cell biological effect assays listed in this document may not be necessary. Cell biological effect assays and evaluation indicators not specified in this document may be used, but the cell biological effect assays and evaluation indicators used need to be verified. The evaluation criteria provide a reasonable explanation. Quantitative evaluation of cell biological effects is more important for the quality control of cartilage scaffolds.

4.2 The cell biological effects experiments and possible experimental results listed in this document have not yet been confirmed to involve the cartilage scaffold in repairing cartilage. The cellular biological mechanisms, namely the causal relationship with the expected cartilage repair, have not been confirmed.