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Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
Automaticky přeložený název:
Standardní Guide pro hodnocení rozsahu oxidace v polyetylénové svařený formuláře určené pro chirurgických implantátů
NORMA vydána dne 1.11.2013
Označení normy: ASTM F2102-13
Poznámka: NEPLATNÁ
Datum vydání normy: 1.11.2013
Kód zboží: NS-52838
Počet stran: 5
Přibližná hmotnost: 15 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
FTIR, implant, oxidation, oxidation index, UHMWPE, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||
1.1 This guide covers a method for the measurement of the relative extent of oxidation present in HDPE homopolymers and ultra-high-molecular-weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy. The intensity (area) of the carbonyl absorptions (>C=O) centered near 1720 cm-1 is related to the amount of chemically bound oxygen present in the material. Other forms of chemically bound oxygen (C-O-C, C-O-O-C, C-O-H, and so forth) are not captured by this guide. 1.2 Although this guide may give the investigator a means to compare the relative extent of carbonyl oxidation present in various UHMWPE samples, it is recognized that other forms of chemically bound oxygen may be important contributors to these materials' characteristics. 1.3 FIG. 1 Typical FTIR Spectra of
Oxidized UHMWPE, Showing the Definition of an Area-Based Oxidation
Index Based on Normalization Using the 1370-cm -1
Peak
FIG. 2 FTIR Spectra Showing the
Carbonyl Absorption Bands
1.4 The following
precautionary caveat pertains only to the test method portion,
Section 5, of this specification: This standard may involve
hazardous materials, operations, and equipment. 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 requirements prior to
use.
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2. Referenced Documents | ||
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