T/CSBM 0009-2021 Active Group standards

T/CSBM 0009-2021 Bioceramic β-tricalcium phosphate nano-powder

Publish Date: 2021-04-26 Implement Date: 2021-10-01 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 0009-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2021-04-26

Implement Date: 2021-10-01

Pages: 8 pages

Scope

Main technical content: **Technical requirements:** 1. **Naming convention**: Products can be classified by particle size, with the n-β-TCP abbreviation and a numerical value indicating the particle size. The number represents the particle size value (in nanometers). For products with specified upper and lower size limits, the number sequentially represents the upper limit (maximum particle size) and lower limit (minimum particle size). For example, n-β-TCP 80-40 represents a β-TCP nanopowder with a maximum particle size of no more than 80 nm and a minimum particle size of no less than 40 nm. For products with only an upper size limit, the number represents the maximum particle size (e.g., n-β-TCP 85 represents a β-TCP nanopowder with a maximum particle size of no more than 85 nm). 2. **Appearance**: A white, odorless, and tasteless solid powder with no visible impurities to the naked eye. 3. **Particle size**: The particle size should comply with GB/T 32269, with at least one dimension of the β-TCP nanopowder being within 100 nm. 4. **XRD analysis**: The X-ray diffraction spectrum should comply with JCPDF powder diffraction card No. 09-0169. Crystallinity: No obvious peaks of other calcium phosphates or crystalline substances, and no obvious amorphous substances. The content of β-TCP crystalline phase should be no less than 95%. 5. **IR absorption spectrum**: There should be absorption peaks of phosphate ions at 1078, 1044, 972, 606, and 552 cm(-1), with no absorption peaks of carbonate ions, carbon-based compounds, amino acids, or other impurities. 6. **Ca/P atomic ratio**: The Ca/P atomic ratio should be 1.50 ± 0.02. 7. **Trace element content (expressed in mg/kg)**: Arsenic < 3 mg/kg, cadmium < 5 mg/kg, mercury < 5 mg/kg, lead < 30 mg/kg. For all metals or oxides not calculated as lead, if their concentration is greater than or equal to 0.1%, it is recommended to list them on a separate page and attach them to the packaging. 8. **Biocompatibili