T/CSBM 0049-2024 Active Group standards

T/CSBM 0049-2024 The testing methods for the characteristics of the porous structure of calcium phosphate bioceramic

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 0049-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2024-05-14

Implement Date: 2024-10-01

Scope

Scope: This document specifies the test samples, test methods, and reporting content for the porous structure characteristics of calcium phosphate bioceramics. This document is applicable to the testing and evaluation of the porous structure characteristics of calcium phosphate bioceramics; Main technical content: 4 Test samples 4.1 Sample properties The physical properties of the test samples, such as material, shape, structure, size, and density, should meet the requirements of equipment such as mercury porosimetry, scanning electron microscopy, and CT. 4.2 Sample sources 4.2.1 Test samples include but are not limited to the following sources: a) Products; b) Representative samples made from the same material and processing method as the products; c) Samples taken from the products. 4.2.2 The method of sampling from the products should not deform or damage the analyzed samples or introduce other human errors, altering the porous structure characteristics of the analyzed samples. 5 Test methods Total porosity 5.1.1 General principles If the particles are crushed from blocks, the total porosity should be tested before crushing according to Method 5.1.2; if the particles are not crushed from blocks, the total porosity should be tested according to Method 5.1.3 or 5.1.4. 5.1.2 Apparent density method 5.1.2.1 Select a rectangular parallelepiped with a volume of 2 cm3 and use a balance with a precision of 0.01 g and a vernier caliper with a precision of not less than 0.02 mm to measure the mass and dimensions of the sample, and calculate the apparent density of the sample according to Equation (1). ? = ?/?···················································································(1) where: dr — the apparent density of the sample, g/cm3; m — the mass of the sample, g; V — the volume of the sample, cm3. 5.1.2.2 Calculate the theoretical density of the sample according to Equation (2). If the sample contains other calcium p