ASTM F1538-03(2009)

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

STANDARD published on 1.4.2009

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The information about the standard:

Designation standards: ASTM F1538-03(2009)
Note: WITHDRAWN
Publication date standards: 1.4.2009
SKU: NS-50663
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F1538-03(2009) :

Keywords:
bioactive glass, bioactive glass-ceramics, glass biomaterials, glass-ceramic biomaterial, surgical implants, Bioactive glass/glass-ceramics, Ceramic materials/applications--specifications, Coatings (surgical implants)--specifications, Glass--specifications, Glass-ceramic biomaterial, Powdered surgical implants, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

1. Scope

1.1 This specification covers the material requirements and characterization techniques for glass and glass-ceramic biomaterials intended for use as bulk porous or powdered surgical implants, or as coatings on surgical devices, but not including drug delivery systems.

1.2 The biological response to glass and glass-ceramic biomaterials in bone and soft tissue has been demonstrated in clinical use (1-12) and laboratory studies (13-17).

1.3 This specification excludes synthetic hydroxylapatite, hydroxylapatite coatings, aluminum oxide ceramics, alpha- and beta-tricalcium phosphate, and whitlockite.

1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.

2. Referenced Documents

C1070-01(2020)	Standard Test Method for Determining Particle Size Distribution of Alumina or Quartz by Laser Light Scattering
C1069-09(2022)	Standard Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
Cadmium
Heavy Metals <231>	Method I
C693-93(2019)	Standard Test Method for Density of Glass by Buoyancy
C729-11(2022)	Standard Test Method for Density of Glass by the Sink-Float Comparator
C730-98(2021)	Standard Test Method for Knoop Indentation Hardness of Glass
C958-92(2022)	Standard Test Method for Particle Size Distribution of Alumina or Quartz by X-Ray Monitoring of Gravity Sedimentation
C623-21	Standard Test Method for Young's Modulus, Shear Modulus, and Poisson's Ratio for Glass and Glass-Ceramics by Resonance
C633-13(2021)	Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
C373-18(2023)	Standard Test Methods for Determination of Water Absorption and Associated Properties by Vacuum Method for Pressed Ceramic Tiles and Glass Tiles and Boil Method for Extruded Ceramic Tiles and Non-tile Fired Ceramic Whiteware Products
C169-16(2022)	Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
C158-23	Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
E228-22	Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer

F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices