T/CSBM 0030-2023 Active Group standards

T/CSBM 0030-2023 Surgical Implants and Additive Manufacturing of β-Tricalcium Phosphate Powder

Publish Date: 2023-04-24 Implement Date: 2023-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/CSBM 0030-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2023-04-24

Implement Date: 2023-10-01

Scope

Main Technical Content: 5. Technical Requirements 5.1 Appearance: The β-TCP powder should be white, with no visible impurities. After irradiation sterilization, it may appear slightly yellow or light brown. 5.2 β-TCP Content: The β-TCP content should be no less than 95wt%. 5.3 Calcium-phosphorus atomic ratio (Ca/P): The Ca/P ratio should be 1.50 ± 0.03. 5.4 Phase Composition and Content 5.4.1 Infrared absorption spectrum: There should be absorption peaks of phosphate (PO2) at 552 cm2, 609 cm2, 944 cm1, and 1043 cm2. There should be no absorption peaks of CPP (CaaP?O?) at 757 cm2, 434 cm2, 1210 cm1, 1185 cm', 723 cm', and 454 cm1. No absorption peaks of carbonate (CO3), carbonyl (C=O), amino groups (-NH2), or other impurities should be present. 5.4.2 β-TCP powder X-ray diffraction spectrum should comply with JCPDS 09-0169. 5.5 Particle Size Determination: Determine the minimum and maximum sizes of D10, D50, and D90 particles, and calculate the average value and standard deviation. 5.6 Particle Shape Determination: Determine the shape and appearance of the powder, which affects slurry preparation, fluidity, and the mechanical strength of 3D-printed components. 5.7 Specific Surface Area: The specific surface area should meet the requirements of specific AM processing techniques and product quality control. 5.8 Bulk Density: The bulk density should meet the requirements of specific AM processing techniques and product quality control. 5.9 Tapped Density: The tapped density should meet the requirements of specific AM processing techniques and product quality control. 5.10 Fluidity: The fluidity should meet the requirements of specific AM processing techniques and product quality control. 5.11 Relative Fluidity of Slurry: Determine the viscosity of ceramic slurries with different solid contents (e.g., 50wt%, 60wt%, 70wt%, 80wt%). 5.12 pH Value: The pH value of the leachate should be 7.0 ± 0.5. After testing, the pH change should not exceed 0.