Standard No.:	YY/T 0683-2008
English Name:	Standard specification for beta-tricalcium phosphate for surgical implantation
Chinese Name:	外科植入物用β-磷酸三钙
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	SFDA
Issued on:	2008-10-17
Implemented on:	2010-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5000 words
Translation Price(USD):	130.0
Delivery:	via email in 1 business day

YY/T 0683-2008 Standard specification for beta-tricalcium phosphate for surgical implantation 1 Scope This standard specifies the chemical and crystallo-graphic requirements for biocompatible beta-tricalcium phosphate (β-TCP) for surgical implant applications. It applies to medical grade beta-tricalcium phosphate (see Annex A). 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. GB/T 16886 (all parts) Biological evaluation of medical devices (idt ISO 10993) Pharmacopoeia of the People’s Republic of China (Volume II) (Edition 2005) YY/T 0287 Medical devices - Quality management systems - Requirements for regulatory purposes (YY/T 0287-2003, ISO 13485:2003, IDT) United States Pharmacopeia (USP) Documents: Identification Tests for Calcium and Phosphate <191> ASTM F 748 Practice for Selecting Generic Biological Test Methods for Materials and Devices ASTM F 981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone U.S. Geological Survey Method 3 Chemical requirements 3.1 Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of beta-tricalcium phosphate [Ca₃(PO₄)₂]. The calcium and phosphorus content shall be determined using a suitable method such as USP <191> or X-ray fluorescence. 3.2 A quantitative X-ray diffraction analysis shall indicate a minimum beta-tricalcium phosphate content of 95% as determined using Powder Diffraction File #550898 and a method equivalent to Forman or Rietveld. 3.3 For beta-tricalcium phosphate, the concentration of trace elements shall be limited as follows: Pb ≤ 30 μg/g Hg ≤ 5 μg/g As ≤ 3 μg/g Cd ≤ 5 μg/g Inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption spectroscopy (AAS), or the methods listed in Clause 2 shall be used. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials of beta-tricalcium phosphate. 3.4 The maximum allowable limit of all heavy metals (by Pb) determined as lead will be 50 μg/g as described in the Pharmacopoeia of the People’s Republic of China or equivalent. Sample preparation for tribasic calcium phosphate shall meet the requirements of the Pharmacopoeia of the People’s Republic of China.

Contents Foreword I 1 Scope 2 Normative references 3 Chemical requirements 4 Quality program requirements 5 Keywords Annex A (Informative) Rationale Annex B (Informative) Biocompatibility Annex C (Informative) Test method of beta-tricalcium phosphate content