T/CSBM 0050.2-2024 Active Group standards

T/CSBM 0050.2-2024 Evaluation of Wound Repair Materials: Part 2: In Vitro Evaluation Method for Water-insoluble Materials Extraction Liquor

Publish Date: 2024-05-14 Implement Date: 2024-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBM 0050.2-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical instruments and materials

Publish Date: 2024-05-14

Implement Date: 2024-10-01

Scope

Scope: This document specifies the preparation of extract solutions, cell proliferation assays, and cell migration assays for the in vitro evaluation of water-insoluble wound repair materials. This document is applicable to the evaluation of the effects of water-insoluble wound repair biomaterials on cell proliferation and migration, such as porous sponge materials, hydrogel materials, etc. Main technical content: 4. Preparation of extract solutions: Under sterile conditions, extract solutions are prepared according to the following conditions: a) Extraction temperature: 37 ± 1 °C; b) Extraction time: 24 ± 2 h or 48 ± 2 h or 72 ± 2 h; c) Extraction medium: serum-free culture medium; d) Extraction conditions: shaking at 120 r/min in a shaking incubator; e) Proportion of samples and extraction medium: in accordance with Table 1 of GB/T 16886.12-2023. 5. Cell proliferation assay 5.1 Principle: Determine the cell proliferation under serum-free culture medium conditions, with serum-free culture medium as the blank control and serum-containing culture medium as the positive control. If the material has the effect of promoting cell proliferation, there will be a significant cell proliferation response compared with the blank control. 5.2 Instruments, reagents, and consumables, cell lines 5.2.1 Instruments: a) CO2 cell culture incubator; b) Constant-temperature water bath shaker; c) High-pressure steam sterilizer; d) Inverted fluorescence microscope; e) Cell counter; f) Constant-temperature water bath shaker; g) Enzyme reader; h) Electronic balance; i) Liquid nitrogen tank; j) Freezer centrifuge; k) 96-well plate; l) Cell culture flask or cell culture dish. 5.2.2 Reagents and consumables: a) DMEM low-sugar medium containing 10% fetal bovine serum (DMEM low-sugar medium containing 10% FBS); b) Serum-free culture medium; c) CCK-8 reagent. 5.2.3 Cell lines 5.2.3.1 Cell lines that can be used in the experiment include: a) Fibroblasts; b)