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GB 23101.2-2008: Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite
GB 23101.2-2008
Implants for surgery.Hydroxyapatite.Part 2. Coatings of hydroxyapatite
ICS 11.040.40
C35
National Standards of People's Republic of China
GB 23101.2-2008/ISO 13779-2.2000
Surgical implants of hydroxyapatite
Part 2. hydroxyapatite coating
(ISO 13779-2.2000, IDT)
Published 2008-12-30
2010-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
All technical contents of this section is mandatory.
GB 23101 "surgical implant hydroxyapatite" is divided into four parts.
--- Part 1. Ceramic hydroxyapatite;
--- Part 2. hydroxyapatite coating;
--- Part 3. Chemical analysis and characterization of crystallinity and phase purity;
--- Part 4. Determination of coating adhesion strength.
This section GB 23101 Part 2.
This section identical with ISO 13779-2.2000 "Surgical implant Hydroxyapatite - Part 2. hydroxyapatite coatings."
This section proposed by the State Food and Drug Administration.
This part is the responsibility of the National Surgical implants and orthopedic devices Standardization Technical Committee (SAC/TC110).
This section was drafted. Biomaterials Engineering Research Center of Sichuan University.
The main drafters of this section. to help Yang, Cao Yang, Chen Ji Yong, Zhang Xingdong.
GB 23101.2-2008/ISO 13779-2.2000
introduction
Currently known surgical implant material has not been demonstrated to completely non-toxic side effects on the human body. However, this section relates to the material
In long-term clinical applications show that if applied properly, the expected level of biological response is acceptable.
The biological response of hydroxyapatite ceramic has proven long-term clinical application and research institute laboratories. See references.
GB 23101.2-2008/ISO 13779-2.2000
Surgical implants of hydroxyapatite
Part 2. hydroxyapatite coating
Range 1
This section specifies the requirements of GB 23101 hydroxyapatite ceramic coating is applied to the metal and non-metallic surgical implant.
This part is not used in the coating of glass, glass ceramic, alpha] and ??- tricalcium phosphate, calcium phosphate, or other forms produced, does not apply to
Hydroxyapatite coating present in a powder state.
2 Normative references
Terms of the following documents constitute provisions of this section by reference in this part of GB 23101. For dated reference documents
Pieces, all subsequent amendments (excluding corrections) or revisions do not apply to this section, however, encouraged to reach under this section
Whether the parties to the agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this
section.
GB/T 16886.17 Biological evaluation of medical devices - Part 17. determination processing residues based on the evaluation of health risks and allow
Xu limit (GB/T 16886.17-2005, ISO 10993-17.2002, IDT)
ISO 13779-3 surgical implant Hydroxyapatite - Part 3. Chemical analysis and characterization of crystallinity and phase purity
Part 4 GB 23101.4 surgical implant hydroxyapatite. Determination of coating adhesion strength (GB 23101.4-2008,
ISO 13779-4.2002, IDT)
3 Terms and Definitions
The following terms and definitions apply to this part of GB 23101.
3.1
Powder grains fused to each other to become the hydroxyapatite block agglomerated.
3.2
Chemical bonding with the International Committee for Diffraction Data (ICDD), USA card PDF9-432 powder diffraction crystal structure characterized by
As it was.
Note. the formula Ca5 (OH) (PO4) 3.
3.3
Deposited by the method of any one of the following metals or nonmetals hydroxyapatite surface of the substrate. generating by a ceramic thermal spray process
Type coating, the solution can be deposited directly by hydroxyapatite deposition or may require heat treatment or other treatment process to convert it to a crystalline state.
4 Requirements
4.1 Chemical Analysis
Calcium hydroxyapatite ceramic content of the coating was measured by the method prescribed in ISO 13779-3. Atomic ratio of calcium and phosphorus which, Ca/P, should
Between 1.67???Ca/P???1.76. Atomic Ratio of calcium and phosphorus by the method prescribed in ISO 13779-3.
Trace Elements 4.2
Hydroxyapatite ceramic content of the specific limit of trace elements in Table 1.
GB 23101.2-2008/ISO 13779-2.2000
Can cause adverse biological response is the maximum allowable total metal 50mg/kg. Determination of Trace Elements shall be ISO 13779-3
The provisions.
Other risk evaluation of chemical impurities caused in accordance with predetermined GB/T 16886.17's.
Table 1 specific limit content of trace elements
Maximum content element/(mg/kg)
Arsenic (As) 3
Cadmium (Cd) 5
Mercury (Hg) 5
Lead (Pb) 30
4.3 crystalline phase content
Hydroxyapatite crystalline phase content of not less than 45%, the maximum allowable content of other crystalline phases is 5%, the balance being an amorphous phase.
Quantitative analysis of hydroxyapatite crystals and other crystalline phase content in accordance with ISO 13779-3.
4.4 the bond strength of the base body
The method described in GB 23101.4 measuring the bond strength of the base material, the strength of not less than 15MPa.
OSI/8002-
2.