ASTM F 1538 : 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Hardcopy , PDF
11-11-2014
English
10-04-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.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.
| Committee |
F 04
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| DocumentType |
Standard
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| Pages |
4
|
| ProductNote |
Reconfirmed 2003
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
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.
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| 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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