YY/T 1744-2020Tissue engineering medical device products—Bioactive ceramics—Method to measure cell migration in porous materials (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the redrafting method to modify and adopt ISO 19090:2018 ``Tissue Engineering Medical Products Bioactive Ceramic Porous Materials Method for measuring cell migration in the middle of the world.

The technical differences between this standard and ISO 19090:2018 and the reasons are as follows:

--- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows:

- Replace ISO 10993-5 with GB/T 16886.5 which is equivalent to the international standard. This standard also made the following editorial changes.

--- Deleted Appendix A (informative appendix) "Experimental results used to determine experimental conditions" of ISO 19090:2018;

--- Deleted Appendix B (informative appendix) "International Comparison Cycle Test Results" of ISO 19090:2018.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

Introduction

Bioactive ceramics are widely used in orthopedics and dentistry because of their good bioactivity and biocompatibility. And porous Bioactive ceramics, cells can enter the pores from the tissues, thus having the potential to effectively repair bone defects, and become a bone tissue engineering medical product. One of the potential candidate "raw materials" for cell scaffolds.

In order to prove the clinical safety and effectiveness of bioactive ceramics, its physical, chemical and biological properties must first be tested. At the place Among the methods used, animal testing is the most important and necessary method to detect the biological characteristics of bioactive ceramics; however, in the 3R principle (instead of Substitute replacement, reduce reduction, optimize refinement), the number of animals and animal experiments must be reduced.

Cell migration ability is the first and most important property of porous biomaterials (including bioactive ceramics). In porous biomaterials and their In the surrounding environment, if there is no cell migration, cell proliferation, differentiation, tissue formation and tissue maturation will not occur.

There are currently two cell seeding methods used to test cell migration ability. one is to drop the cell suspension onto the surface of the porous material.

The penetration ability of the cell suspension under the action of gravity was tested; the other is to add porous materials to the cell suspension to drive the cells into Into the material. These two methods can only detect the penetration and retention ability of cells, but they cannot simulate cell migration in the body. body fluid It is sufficient by itself to carry cells through the small gap between the implant material and the host bone tissue. Therefore, there is currently no simulation of cell behavior in vivo The report of the cell migration test method.

When the porous bioceramic is implanted in the bone defect, the cells migrate into the hole to form new bone. In this process, the migration of osteoblasts Play an important role in bone conduction. In other words, without osteoblast migration, there will be no bone conduction or bone formation.

Therefore, it is necessary to establish a method that can quantify and simulate the behavior of cells in the body to measure the cell migration potential of porous bioactive ceramics.

Yes, in order to objectively evaluate its potential as a scaffold material for tissue engineering medical products.

The standard drafting group adopted the following four materials. HT (HA. beta-TCP=8. 2, average pore size 312.3µm, porosity 80.9%, pore structure is disordered, spherical), HTL (HA. beta-TCP=6. 4, average pore size 390.3µm, porosity 81.7%, pore structure Disordered, spherical), TH (HA. beta-TCP=1. 9, average pore size 375.4µm, porosity 81.6%, pore structure is disordered, spherical), THL (HA. beta-TCP=3. 7, average pore diameter 293.8µm, porosity 77.7%, pore structure is disordered, spherical), which verifies this standard The method given in is feasible and operable for evaluating the cell migration potential of porous bioceramics.

1 Scope

This standard specifies test methods for measuring and recording cell migration in porous bioactive ceramic materials.

This standard applies to porous bioactive ceramics.

This standard does not apply to porous materials with low or no cell adhesion, such as synthetic polymers and metals.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 16886.5 Biological evaluation of medical devices Part 5. In vitro cytotoxicity test (GB/T 16886.5-2017, ISO 10993-5:2009, IDT)

3 Terms and definitions

The following terms and definitions apply to this document.