Standard No.:	YY/T 0964-2014
English Name:	Implants for surgery―Bioglass and glass ceramic biomaterials
Chinese Name:	外科植入物 生物玻璃和玻璃陶瓷材料
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	China Food and Drug Administration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	4000 words
Price(USD):	100.0
Delivery:	via email in 1 business day

1 Scope This standard covers the material requirements and testing technology of bioglass and glass ceramic used for implants for surgery; the biomaterials listed in this standard may be used for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems. The biological response to bioglass and glass ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use and laboratory studies. This standard excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite. 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative document (including any amendments) applies. GB/T 1347 Methods for Chemical Analysis of Soda-lime-silica Glass GB/T 5432 Test Method for Density of Glass by Buoyancy GB/T 6040 General Rules for Infrared Analysis GB/T 6524 Metallic Powders - Determination of Particle Size Distribution by Gravitational Sedimentation in a Liquid and Attenuation Measurement GB/T 6609.35 Chemical Analysis Methods and Determination of Physical Performance of Alumina - Part 35: Determination of Specific Surface Area by Nitrogen Adsorption GB/T 14901 Test Method for Density of Glass - Method of the Sink-float Comparison GB/T 16534 Fine Ceramics (Advanced Ceramics, Advanced Technical Ceramics) - Test Method for Hardness of Monolithic Ceramics at Room Temperature GB/T 16535 Fine Ceramics (Advanced Ceramics Advanced Technical Ceramics) - Test Method for Linear Thermal Expansion of Monolithic Ceramics by Push-rod Technique (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 Particle Size Analysis - Laser Diffraction Method - Part 1: General Principles (GB/T 19077.1-2008, ISO 13320-1: 1999, IDT) GB 23101.4 Implants for Surgery - Hydroxyapatite - Part 4 : Determination of Coating Adhesion Strength (GB 23101.4-2008, ISO 13779-4:2002.IDT) Pharmacopoeia of People's Republic of China (Part II) JC/T 676 Test Method for Flexure of Glass Material JC/T 678 Test Method for Youngs Modulus Sheat Modulus and Poissons Ratio of Glass Material JY/T 009 General Rules for X-ray Polycrystalline Diffractometry QB/T 3572 Chemical Analysis Method of Borosilicate Glass ASTM C 633 Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings 3 Terms and Definitions

Foreword I 1 Scope 2 Normative References 3 Terms and Definitions 4 Chemical Requirements 5 Physical Characterization 6 Biocompatibility 7 Test Specimen Preparation Appendix A (Informative) Rationale Appendix B (Informative) Biocompatibility Appendix C (Informative) Test Method for In Vitro Sedimentary Hydroxycarbonate Apatite Appendix D (Informative) Indicative Information for Mercury References