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YY/T 0964-2014: Implants for surgery. Bioglass and glass ceramic biomaterials
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| YY/T 0964-2014 | English | 299 |
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Implants for surgery. Bioglass and glass ceramic biomaterials
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YY/T 0964-2014
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Basic data | Standard ID | YY/T 0964-2014 (YY/T0964-2014) | | Description (Translated English) | Implants for surgery. Bioglass and glass ceramic biomaterials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 13,117 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 1347; GB/T 5432; GB/T 6040; GB/T 6524; GB/T 6609.35; GB/T 14901; GB/T 16534; GB/T 16535; GB/T 16886.1; GB/T 19077.1; GB 23101.4; JC/T 676; JC/T 678; JY/T 009; QB/T 3572; ASTM C633 | | Adopted Standard | ASTM F1538-2003, NEQ | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to surgical implants bioactive glass and glass-ceramic materials. This Standard specifies the surgical implants bioactive glass and glass-ceramic material requirements and testing techniques. This Standard of the material can be used | YY/T 0964-2014: Implants for surgery. Bioglass and glass ceramic biomaterials---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. Bioglass and glass ceramic biomaterials
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Surgical implants bioactive glass and glass-ceramic material
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference ASTMF1538-03 "surgical implants bioactive glass and glass-ceramic materials," this standard and ASTMF1538-03
The main difference is that. This standard uses the applicable national standards or industry standards instead of ASTM standards; increasing the biological activity of the test material
method.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee materials and orthopedic implants Technical Committee
(SAC/TC110/SC1) centralized.
This standard was drafted. Shanghai Institute of Ceramics, Chinese Academy of Sciences, Tianjin Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Lin Kaili, Chang Jiang, Ma Chun Bao, makin bamboo, Li Libin.
Surgical implants bioactive glass and glass-ceramic material
1 Scope
This standard specifies the surgical implant with bioactive glass and glass ceramic materials requirements and testing technology, the material can be used in the present standard
Porous and powdered surgical implants, can also be used to coat surgical instruments, but does not include a drug delivery system. Bioactive glass and glass ceramics
Biological response and bone and soft tissue has been proven in laboratory studies and clinical applications.
This standard does not contain the tricalcium synthetic hydroxyapatite, hydroxyapatite coating, alumina ceramic, α- and β- tricalcium phosphate and white phosphorus
Calcium stone.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1347 soda-lime-silica glass chemical analysis
GB/T 5432 glass densitometry buoyancy method
GB/T 6040 General rules for infrared spectroscopy
Gravity measurements GB/T 6524 metal powder particle size distribution sedimentation light transmission method
GB/T 6609.35 alumina chemical analysis methods and determination of physical performance - Part 35. Determination of nitrogen than the surface area of absorption
Attached law
GB/T 14901 glass densitometry ups and downs of Comparative Law
GB/T 16534 Test method for hardness of fine ceramics at room temperature
GB/T 16535 Fine Ceramics linear thermal expansion coefficient Test Method ram method (GB/T 16535-2008, ISO 17562.2001,
MOD)
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing
GB/T 19077.1 laser diffraction particle size analysis - Part 1. General (GB/T 19077.1-2008, ISO 13320-1.
1999, IDT)
Section 4 GB 23101.4 surgical implants hydroxyapatite. Determination of coating adhesion strength (GB 23101.4-2008,
ISO 13779-4.2002.IDT)
People's Republic of China Pharmacopoeia (two)
Strength test methods JC/T 676 curved glass
JC/T 678 glass material elastic modulus, shear modulus and Poisson's ratio test method
JY/T 009 rotating anode X-ray diffraction of polycrystalline General
QB/T 3572 Methods for chemical analysis of borosilicate glass
ASTMC633 thermal spray coating adhesion or bonding strength test method (TestMethodforAdhesionorCohesion
StrengthofThermalSprayCoatings)
3 Terms and Definitions
The following terms and definitions apply to this document.
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