T/CSBM 0050.1-2024 Active Group standards

T/CSBM 0050.1-2024 Assessment of the effectiveness of wound healing materials - Part 1: In vitro evaluation methods for water-soluble materials

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 0050.1-2024

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 cytotoxicity test, cell proliferation test, and cell migration test for the in vitro evaluation of water-soluble wound repair materials. This document is applicable to the evaluation of the effects of water-soluble wound repair biomaterials in promoting cell proliferation and migration. Main Technical Content: 4. Cytotoxicity Test 4.1 Principle: Dissolve the tested biomaterial in culture medium to prepare samples of different concentration gradients, and determine whether the material is cytotoxic at different concentrations according to GB/T 16886.5-2017. 4.2 Equipment, Reagents, and Supplies, Cell Lines 4.2.1 Test Equipment: 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 labeler; h) Electronic balance; i) Liquid nitrogen tank; j) Freezing centrifuge; k) 96-well plate; l) Cell culture flask or Petri dish. 4.2.2 Reagents and Supplies: a) DMEM low-sugar medium containing 10% FBS (DMEM low-sugar medium with 10% FBS); b) Dimethyl sulfoxide (DMSO); c) Isopropanol; d) High-density polyethylene. 4.2.3 Cell Lines: L929 cells. 4.3 Sample Preparation 4.3.1 Prepare test samples by accurately weighing the samples and dissolving them in DMEM low-sugar medium containing 10% FBS to prepare samples of different concentration gradients, and then filter and sterilize them for storage. Based on the existing cytotoxicity data of the samples, prepare 10 different concentration gradients of test samples. 4.3.2 Negative Control: Calculate the area of the high-density polyethylene double side with a diameter of 1 cm, add 10% FBS DMEM low-sugar medium at a ratio of 3 cm2/mL, and incubate at 37°C and 120 rpm for 24 h. Use the extracted solution for testing. 4.3.3 Positive Control: Add an appropriate amount of DMSO to DMEM low-sugar me