YY/T 0964-2014Implants for surgery - Bioglass and glass ceramic biomaterials (English PDF)

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, alpha- and beta- 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.