Wir benötigen Ihre Einwilligung zur Verwendung der einzelnen Daten, damit Sie unter anderem Informationen zu Ihren Interessen einsehen können. Klicken Sie auf "OK", um Ihre Zustimmung zu erteilen.
Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
Name übersetzen
NORM herausgegeben am 15.4.2023
Bezeichnung normen: ASTM F1185-23
Ausgabedatum normen: 15.4.2023
SKU: NS-1141614
Zahl der Seiten: 4
Gewicht ca.: 12 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
This specification covers chemical and crystallographic requirements for hydroxylapatite intended for surgical implants. Elemental analysis for calcium and phosphorus will be consistent with the expected stoichiometry of hydroxylapatite. The calcium and phosphorus contents shall be determined using a suitable method such as ion chromatography. A quantitative X-ray diffraction analysis shall indicate a minimum hydroxylapatite content of 95 %. The concentration of trace elements such as arsenic, cadmium, mercury, and lead shall be determined for hydroxylapatite derived from natural resources. The analysis of other trace elements may be required, based on the conditions, apparatus, or environments specific to the manufacturing techniques and raw materials. Either inductively coupled plasma/mass spectroscopy (ICP/MS), atomic absorption (AAS), or the methods mentioned shall be used.
Keywords:
bioceramic, bone graft, hydroxylapatite (HA), hydroxyapatite, tricalcium phosphate (TCP), whitlockite,, 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 medical-grade 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)2 and by laboratory studies 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 F1088). 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
||||||||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||||||||
|
Wollen Sie sich sicher sein, dass Sie nur die gültigen technischen Normen verwenden?
Wir bieten Ihnen eine Lösung, die Ihnen eine Monatsübersicht über die Aktualität der von Ihnen angewandten Normen sicher stellt.
Brauchen Sie mehr Informationen? Sehen Sie sich diese Seite an.
Letzte Aktualisierung: 2024-12-22 (Zahl der Positionen: 2 217 000)
© Copyright 2024 NORMSERVIS s.r.o.