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GB 23101.1-2008: Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite
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Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite
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GB 23101.1-2008
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Basic data | Standard ID | GB 23101.1-2008 (GB23101.1-2008) | | Description (Translated English) | Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite | | Sector / Industry | National Standard | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 7,717 | | Date of Issue | 2008-12-30 | | Date of Implementation | 2010-03-01 | | Quoted Standard | GB/T 16886.17; ISO 13779-3 | | Adopted Standard | ISO 13779-1-2000, IDT | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 26 of 2008 (total 139) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard relates to surgical implants hydroxyapatite ceramic requirements. This standard does not apply to hydroxyapatite coating, non-ceramic hydroxyapatite, hydroxyapatite powder, glass, ceramics, ��- and ��- tricalcium phosphate or other forms of calcium phosphate. | GB 23101.1-2008: Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatite---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for surgery.Hydroxyapatite.Part 1. Ceramic hydroxyapatite
ICS 11.040.40
C35
National Standards of People's Republic of China
GB 23101.1-2008/ISO 13779-1.2000
Surgical implants of hydroxyapatite
Part 1. Ceramic hydroxyapatite
(ISO 13779-1.2000, 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 1.
This section identical with ISO 13779-1.2000 "surgical implants Hydroxyapatite - Part 1. hydroxyapatite ceramic."
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. Fan Hongsong, Zhao Huichuan, Zhang Xingdong.
GB 23101.1-2008/ISO 13779-1.2000
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 23101.1-2008/ISO 13779-1.2000
Surgical implants of hydroxyapatite
Part 1. Ceramic hydroxyapatite
Range 1
This section specifies the requirements of GB 23101 as hydroxyapatite ceramic surgical implant.
This does not apply to hydroxyapatite coating, non-ceramic hydroxyapatite, hydroxyapatite powder, glass ceramic, alpha] and β- tricalcium phosphate
Or other forms of calcium phosphate.
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. leachables allows the establishment of limits (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
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. Chemical formula. Ca5 (OH) (PO4) 3.
3.3
By heating the powder particles and the surface area of the entire volume of the powder decreases significantly densified and to improve the mechanical properties of ceramic followed by
production process.
4. Technical Requirements
4.1 Chemical Analysis
Determination of calcium hydroxyapatite ceramic content should be defined by ISO method 13779-3. Atomic ratio of calcium and phosphorus which, Ca/P, be mediated
In 1.65≤Ca/P≤1.82. Atomic Ratio of calcium and phosphorus by the method prescribed in ISO 13779-3.
Trace Elements 4.2
Limit hydroxyapatite ceramic content of the specific trace elements are shown in Table 1.
Can cause adverse biological response is the maximum allowable total metal 50mg/kg. Determination of Trace Elements shall be ISO 13779-3
GB 23101.1-2008/ISO 13779-1.2000
The provisions.
Evaluation of other dangerous chemical impurities caused should be GB/T 16886.17 carried out.
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 should be less than 95%. The maximum content of the other crystal phase allows 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 Mechanical Properties --- compressive strength
Compressive strength of sintered hydroxyapatite ceramic is not lower than 1.5MPa, and should not show anisotropy.
Average compressive strength should begin breaking load force moment is calculated by measuring the recording.
GB 23101.1-2008/ISO 13779-1.2000
[11] J. H. QUINNandJ. N. KENT, AlveolarRidgeMaintenancewithSolidNon-porous
HydroxyapatiteRootImplants. OralSurg. , 58, pp. 511-516,1984.
[12] K. DEGROOT, BioceramicsofCalciumPhosphate, CRCPress, BocaRaton, USA, 1983.
[13] H. OONISHIetal. , ClinicalSignificanceofChemicalBondsbetweenBioactiveCeramics
andBonein OrthopaedicSurgery, in. Bioceramics2, G Heimke (. ed), Deutsche Keramische
Geselschaft.
[14] R. Z. LEGEROSandJ. P. LEGEROS, DenseHydroxyapaptite, inAnIntroductionto
Bioceramics, L. HenchandJ. Wilson (eds.), WorldScientific, 1993, pp. 199-221.
GB 23101.1-2008/ISO 13779-1.2000
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