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YY/T 0683-2008: Standard specification for beta-tricalcium phosphate for surgical implantation
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YY/T 0683-2008: Standard specification for beta-tricalcium phosphate for surgical implantation

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Standard specification for beta-tricalcium phosphate for surgical implantation ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Surgical implants with calcium phosphates three β- (ASTMF1088-04a, IDT) Posted 2008-10-17 2010-01-01 implementation State Food and Drug Administration issued

Foreword

β- 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 β- tricalcium phosphate "standard. Chemical covered by this standard β- tricalcium phosphate, calcium material composition, physical properties and chemical testing methods and students Substance evaluation. Appendix C recommended test method β- tricalcium phosphate content. This standard is equivalent to using ASTMF1088-04a "surgical implants β- tricalcium phosphate." This standard Annex A, Annex B, Annex C is informative appendix. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) and focal points. This standard was drafted. Biological Material Co., Ltd. on Haibei Ao Road, Tianjin, the State Food and Drug Administration Medical Device Quality Supervision Inspection Center, Shanghai Institute of Ceramics, Chinese Academy of Sciences, Shanghai Second Medical University Affiliated Ninth People's Hospital. The main drafters of this standard. Lu Jianxi, the Hong Zhou, Ma Chun Bao Fan platinum, Lin Kaili, Chang Jiang, thank the young professionals. Surgical implants with calcium phosphates three β-

1 Scope

This standard specifies the requirements for chemical crystallography and surgical implants biocompatible β- tricalcium phosphate (β-TCP) material. This standard Suitable medical grade β- 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 β- 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 β- 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 β- 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 β- 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; β-TCP; β- tricalcium phosphate; calcium phosphate materials; ceramics; surgical implants. ...