T/CSBM 0010-2021 Active Group standards

T/CSBM 0010-2021 Biomedical hydroxyapatite 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 0010-2021

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 hydroxyapatite nanopowder abbreviated as **n-HAP** followed by a number. The number represents the particle size value (in nanometers). For products with specified upper and lower size limits, the number sequentially indicates the upper limit (maximum size) and lower limit (minimum size) of the particle size range. For example, **n-HAP 80-40** represents a HAP nanopowder with a maximum size of no more than 80 nm and a minimum size of no less than 40 nm. For products with only an upper size limit requirement, the number indicates the upper limit (maximum size) of the particle size, such as **n-HAP 85**, which represents a HAP nanopowder with a maximum size of no more than 85 nm. 2. **Appearance**: A white, odorless, and tasteless solid powder with no visible foreign matter. 3. **Particle size**: The particle size should comply with the provisions of GB/T 32269, with the size of the hydroxyapatite nanopowder having at least one dimension within 100 nm. 4. **X-ray diffraction analysis**: The X-ray diffraction spectrum should comply with the JCPDF powder diffraction card No. 09-0432. Crystallinity: No obvious peaks of other calcium phosphates or crystalline substances, and no obvious non-crystalline substances. The content of the hydroxyapatite crystalline phase should be no less than 95%. 5. **Infrared absorption spectroscopy**: There should be hydroxylation absorption peaks at 3573 and 632 cm(-1) and phosphate absorption peaks at 1090, 1047, 959, 601, and 571 cm(-1). No absorption peaks of carbonate, carboxyl, amino, or other impurities should appear. 6. **Calcium/phosphorus atomic ratio**: The Ca/P atomic ratio should be 1.67 ± 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