T/CSBM 0025-2022 Active Group standards

T/CSBM 0025-2022 bioactive glass materials for molten method

Publish Date: 2022-04-12 Implement Date: 2022-10-01 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 0025-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2022-04-12

Implement Date: 2022-10-01

Pages: 11 pages

Scope

Main Technical Content: 1. Technical Requirements 1.1 Appearance: White powder, granules, blocks, or fibers, with no visible impurities to the naked eye. 1.2 Chemical Composition: The melt-processed bioactive glass should primarily consist of a Na2O-CaO-SiO2-P2O5 tetravalent system. The SiO2 content should not exceed 58wt%, the Na2O content as the glass network external phase should not exceed 25wt%, the CaO content should not exceed 34wt%, and the P2O5 content should not exceed 12wt%. On this basis, a small amount of elements such as B, Mg, Sr, Cu, F, and K can be added to improve the mechanical and biological properties of the material, with the total addition of these elements not exceeding 5wt%. 1.3 XRD Analysis: In the XRD spectrum, the dominant diffraction peaks are relatively diffuse, with peak widths ranging from 20° to 35°, characteristic of inorganic amorphous materials. 1.4 FTIR Analysis: In the FTIR spectrum, there are absorption peaks characteristic of Si-O-Si bending vibrations at 540 cm-1 to 440 cm-1, Si-O-Si (tetrahedron) vibrations at 1175 cm-1 to 710 cm-1, and Si-O asymmetric stretching vibrations at 1100 cm-1 to 1000 cm-1. 1.5 Heavy Metal Content Limits: The heavy metal content limits should comply with Table 1. Table 1: Heavy Metal Content Limits Item Indicator Arsenic (As), μg/g ≤3 Cadmium (Cd), μg/g ≤5 Mercury (Hg), μg/g ≤5 Lead (Pb), μg/g ≤30 Total Heavy Metal Content (calculated as Pb), μg/g ≤50 1.6 Bioactivity In Vitro Mineralization Experiment: After placing the material in Tris-HCl buffer or simulated body fluid and soaking at 37°C for 48 hours, HCA should be formed on the material surface. With increasing soaking time, the amount of HCA formed on the material surface gradually increases. When the bioactive glass is soaked in the in vitro mineralization solution for a certain period of time, the FTIR spectra of the material samples will undergo certain changes. Among these, the dual vibration absorpt