YY/T 0683-2008Standard specification for beta-tricalcium phosphate for surgical implantation (English PDF)

Foreword

beta-tricalcium phosphate is widely used in clinical medicine, in order to guide the production and market operators to adapt to the requirements of users, specially formulated "outside Section implants beta-tricalcium phosphate "standard. Chemical covered by this standard beta-tricalcium phosphate, calcium material composition, physical properties and chemical testing methods and students Substance evaluation. Appendix C recommended test method beta-tricalcium phosphate content.

This standard is equivalent to using ASTMF1088-04a "surgical implants beta-tricalcium phosphate." This standard Annex A, Annex B, Annex C is informative appendix.

1 Scope

This standard specifies the requirements for chemical crystallography and surgical implants biocompatible beta-tricalcium phosphate (beta-TCP) material. This standard Suitable medical grade beta-tricalcium phosphate material (see Appendix A).

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 16886 (all parts) Biological evaluation of medical devices (idt ISO 10993)

Chinese Pharmacopoeia (2005 edition) two

YY/T 0287 medical device quality management system for regulatory requirements (YY/T 0287-2003, ISO 13485:2003, IDT)

USP. Determination of calcium and phosphorus < 191>

General selection procedures biological test methods ASTMF748 materials and equipment

ASTMF981 Surgical Implants (non-porous) biological materials with compatibility muscle and skeletal assessment procedures

United States Geological Survey Method

3 Chemical requirements

3.1 Elemental analysis for calcium and phosphorus should expect [Ca3 (PO4) 2] theoretical stoichiometric ratio consistent with beta-tricalcium phosphate. Calcium and phosphorus content Tests using appropriate methods, such as "USP" < 191> or X-ray fluorescence method.

3.2 Quantitative X-ray diffraction analysis should indicate that beta-tricalcium phosphate content of not less than 95%. Powder Diffraction File used in the test # 550898, using the test methods and Forman Rietveld phase or equivalent.

3.3 beta-tricalcium phosphate content of trace elements should meet the following requirements.

Lead (Pb) <= 30µg/g Mercury (Hg) <= 5µg/g Arsenic (As) <= 3µg/g Cadmium (Cd) <= 5µg/g Test methods should be used plasma mass spectrometry (ICP/MS) method, atomic absorption spectroscopy (AAS) method, or are listed in Chapter 2.

Depending on the circumstances beta-tricalcium phosphate manufacturing technology and raw materials, equipment or the environment need to analyze the details of the decision whether to test other trace element.

3.4 Total Heavy Metals (Pb) of the maximum allowable amount should be described as Chinese Pharmacopoeia or equivalent documents, the total amount should <=50µg/g. Tricalcium phosphate test sample should follow the "Chinese Pharmacopoeia" requirements.

3.5 For the concentration in the material is greater than or equal to 0.1% of all the metal or oxide material recommendations noted in the description.

4 Quality assurance requirements

Manufacturers should have appropriate quality assurance system, such as compliance with YY/T 0287 requirements of. […]

5 Keywords

Advanced Ceramics; beta-TCP; beta-tricalcium phosphate; calcium phosphate materials; ceramics; surgical implants.