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Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Automaticky preložený názov:
Štandard Specification Sklenené a sklokeramickú biomateriálov pre implantáciu
NORMA vydaná dňa 1.4.2009
Označenie normy: ASTM F1538-03(2009)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.4.2009
Kód tovaru: NS-50663
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
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)
1. Scope | ||||||||||||||||||||||||||||||||||
D
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. |
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2. Referenced Documents | ||||||||||||||||||||||||||||||||||
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