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Standard Test Method for Dissolution Testing of Calcium Phosphate Granules, Fabricated Forms, and Coatings
Automaticky přeložený název:
Standardní zkušební metoda pro rozpouštění testování vápenatofosfátových granulemi, hutních a formy, a nátěrů
NORMA vydána dne 15.5.2014
Označení normy: ASTM F1926/F1926M-14
Poznámka: NEPLATNÁ
Datum vydání normy: 15.5.2014
Kód zboží: NS-52110
Počet stran: 5
Přibližná hmotnost: 15 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
calcium-phosphate, coating, dissolution rate, fabricated form, granule, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Significance and Use | ||||||
4.1 Aspects of the biological response to calcium phosphate materials in soft tissue and bone have been reported from laboratory studies and clinical use (1-11).3 4.2 The requirements of this test method apply to calcium phosphate materials such as calcium hydroxyapatite (see Specification F1185), beta-tricalcium phosphate (see Specification F1088), and biphasic mixtures thereof with or without intentional addition of other minor components (<10 %). 4.3 This test method is limited to the laboratory evaluation of the dissolution rate of a calcium phosphate material. No correlation of the results to in vivo performance is implied. Therefore, it is recommended that a control material be included in the evaluation. The control material can be a standardized material such as NIST SRM 2910 or a historical control. |
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1. Scope | ||||||
1.1 This test method covers calcium phosphate materials intended for use in surgical implant applications. 1.2 The material(s) shall be representative of that produced for sale. It shall have been produced and processed under standard manufacturing conditions. 1.3 The materials may be in the form of powders, granules, spall material, fabricated forms or coatings; and may be porous, nonporous, textured, and other implantable topographical substrate form representative of the end-use product. 1.4 The calcium phosphate material may constitute the only material in a substrate or it may be one of multiple materials so long as all other materials present do not dissolve under the test conditions described in this test method. 1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the 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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