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ASTM F 1538 : 2003

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

04-10-2003

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2017 Defines 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.

1.1 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)2 and laboratory studies (13-17).

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

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2003
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 2027 : 2016 Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products

ASTM E 228 : 2017 : REDLINE Standard Test Method for Linear Thermal Expansion of Solid Materials With a Push-Rod Dilatometer
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM C 693 : 1993 TEST METHOD FOR DENSITY OF GLASS BY BUOYANCY
ASTM C 158 : 2002 Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM C 169 : 2016 : REDLINE Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass

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PDF - English
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