YY/T 1640-2018Implants for surgery—Standard test method for dissolution testing of calcium phosphate granules, fabricated forms and coatings (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the redrafting method with reference to ASTM F1926-2014 "Surgical implant calcium phosphate particles, products and coating solubility The test method was compiled.

1 Scope

This standard specifies test methods for evaluating the dissolution rate of calcium phosphate materials.

This standard applies to calcium phosphate materials for surgical implants, including hydroxyapatite in accordance with GB 23101.1 and GB 23101.2.

YY/T 0683 specifies beta-tricalcium phosphate and a two-phase complex without addition or addition of other minor components (< 10%).

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB 23101.1 Surgical implants hydroxyapatite Part 1. Hydroxyapatite ceramics

GB 23101.2 Surgical implants hydroxyapatite Part 2. Hydroxyapatite coating

YY/T 0683-2008 beta-tricalcium phosphate for surgical implants

3 Terms and definitions

The following terms and definitions apply to this document.

4 Significance and application

4.1 Calcium phosphate material may be a single material or a composite material as long as other materials are described in this test method.

Do not dissolve under the conditions. The biological response of calcium phosphate materials in soft tissue and bone has been studied in laboratory and clinical applications.

4.2 This test method is limited to laboratory evaluation of the dissolution rate of calcium phosphate materials. There are no results related to in vivo performance, so it is recommended Control materials were included in the evaluation. The control material can be a hydroxyapatite standard (NIST) from the National Institute of Standards and Technology.

SRM2910) Such standard materials can also be compared with historical data.

5 Solvent

5.1 The water used to prepare the reagent or solvent needs to be deionized water with carbon dioxide removed, or the residual calcium ion concentration is less than 0.1µg/mL. Distilled water.

5.2 Unbuffered aqueous solution containing 8 x 10^-5 mol/L sodium chloride, 8 x 10^-5 mol/L calcium chloride and 5 x 10^-5 mol/L potassium phosphate