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Standard Specification for Composition of Hydroxylapatite for Surgical Implants
Automaticky preložený názov:
Štandardné špecifikácie pre zloženie hydroxylapatitové pre chirurgických implantátov
NORMA vydaná dňa 15.6.2009
Označenie normy: ASTM F1185-03(2009)
Poznámka: NEPLATNÁ
Dátum vydania normy: 15.6.2009
Kód tovaru: NS-49429
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Keywords:
bioceramic, bone graft, hydroxylapatite (HA), hydroxyapatite, tricalcium phosphate (TCP), whitlockite, Bone implant materials/applications--specifications, Ceramic surgical materials/applications--specifications, Hydroxylapatite (HA), Orthopaedic medical devices--specifications, Orthopaedic medical devices (bone)--specifications, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||||||||||
1.1 This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. For a material to be called hydroxylapatite, it must conform to this specification. (See Appendix X1.) 1.2 The biological response to hydroxylapatite in soft tissue and bone has been characterized by a history of clinical use (1-3) and by laboratory studies (4-6). 1.3 This specification includes powder, particulate, and forms intended for use as surgical implants, components of surgical implants, or as raw materials for manufacturing processes such as thermal spray coating, electrophoretic deposition, physical vapor deposition, and so forth. 1.4 This specification specifically excludes hydroxylapatite coatings, amorphous calcium phosphate, ceramic-glasses, tribasic calcium phosphate, whitlockite, and alpha- and beta-tricalcium phosphate. (See Specification F 1088.) 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. |
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2. Referenced Documents | ||||||||||||||||||||||||
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