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YY/T 1744-2020: Tissue engineering medical device products - Bioactive ceramics - Method to measure cell migration in porous materials
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Tissue engineering medical device products - Bioactive ceramics - Method to measure cell migration in porous materials
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YY/T 1744-2020
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PDF similar to YY/T 1744-2020
Standard similar to YY/T 1744-2020 YY/T 1860.1 YY/T 1748 YY/T 1653 YY/T 1736 Basic data | Standard ID | YY/T 1744-2020 (YY/T1744-2020) | | Description (Translated English) | Tissue engineering medical device products - Bioactive ceramics - Method to measure cell migration in porous materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 16,128 | | Date of Issue | 2020-09-27 | | Date of Implementation | 2021-09-01 | | Regulation (derived from) | Announcement No. 108 (2020) of the National Medical Products Administration | | Issuing agency(ies) | State Drug Administration | YY/T 1744-2020: Tissue engineering medical device products - Bioactive ceramics - Method to measure cell migration in porous materials
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Tissue engineering medical device products Bioactive ceramics Cell migration measurement methods in porous materials)
ICS 11:040:30
C35
People's Republic of China Pharmaceutical Industry Standard
Bioactive ceramics for tissue engineering medical device products
Method for measuring cell migration in porous materials
(ISO 19090:2018Tissue-engineeredmedicalproducts-Bioactive
2020-09-27 release
2021-09-01 implementation
Issued by the State Drug Administration
Table of contents
Preface Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Principle 2
5 Test sample 2
6 Test Step 3
7 Calculation 9
8 Test report 10
Reference 12
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:
This standard was proposed by the State Drug Administration:
This standard is organized by the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices, and the Sub-Technical Committee for Medical Device Products
(SAC/TC110/SC3) Centralized:
Drafting organizations of this standard: Sichuan University (Sichuan Medical Device Biological Materials and Products Inspection Center), China Food and Drug Control Research Institute:
The main drafters of this standard: Liang Jie, Wei Lina, Yang Xiaoqin, Cai Yongfu, Yuan Tun, Zhang Le, Xu Liming:
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: β-TCP=8: 2, average pore size 312:3μm, porosity
80:9%, pore structure is disordered, spherical), HTL (HA: β-TCP=6: 4, average pore size 390:3μm, porosity 81:7%, pore structure
Disordered, spherical), TH (HA: β-TCP=1: 9, average pore size 375:4μm, porosity 81:6%, pore structure is disordered, spherical),
THL (HA: β-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:
Bioactive ceramics for tissue engineering medical device products
Method for measuring cell migration in porous materials
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 article
Pieces: 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:
3:1
Bioceramics
Ceramic materials implanted in the human body to enhance biological functions:
3:2
Bioactive ceramics
A bioceramic with guiding osseointegration performance when implanted in a bone defect:
3:3
Biomaterials
Materials used for diagnosis, treatment, repair or replacement of body tissues and organs or to enhance their functions:
[YY/T 1445-2016, definition 3:19]
3:4
Fulconfluent
The monolayer of cells almost completely (≈95%~100%) covers the cell culture dish:
3:5
Complete medium
Cell culture medium containing all necessary additives for the selected cell type: The cell culture medium has been verified by users
It is beneficial and does not cause cell mutations:
3:6
Osteoblast-likecel
An established cell line that is widely recognized as having "osteogenic activity":
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