ASTM F2459 PDF

New ASTM F Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. ASTM F – Standard Test Method for Extracting Residue from. Metallic Medical Components and Quantifying via Gravimetric. Analysis. • ASTM F a baseline and set acceptance parameters for cleanliness. ASTM F Chemical Residue by. Gravimetric Analysis. This document provides a quantitative.

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ASTM-F, –

This standard does not purport to address all of the safety concerns, if any, associated with its use. This standard does not purport to address all of the safety concerns, if any, associated with its use. This test method is also not intended to extract residue for use in biocompatibility testing.

No other units of measurement are included in this standard. Active view current version of standard. If you like to setup a quick aastm, let us know at support madcad. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

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.

It identifies two techniques to quantify extractable residue on metallic medical components. Link to Active This link will always route 2f459 the current Active version of the standard. Today, some 12, ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. Residues may originate from manufacturing materials used in the course of processing or from the manufacturing environment, or may be the result of handling and packaging 1- 3.

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Link to Active This link f2549 always route to the current Active version of the standard.

This test method recommends the use of a sonication technique to extract residue from the medical component. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to 2f459. Search book title Enter keywords for book title search. Other techniques, such as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.

ASTM F2459 – 18

For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Print 1 2 3 4 5 page sstarting from page current page. Residues may induce no tissue response, minor tissue irritations, or they may lead aztm local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use.

Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO Work Item s – proposed revisions of this standard. Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components. Register r2459 a trial account. Land Use and Development.

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It identifies one technique to quantify extractable residue on metallic medical components. Work Item s – proposed revisions of this standard.

New ASTM F Standard Test Method for Extracting Residue

Other sstm, such as solvent reflux extraction, could be used but have been shown to be less atm in some tests, as discussed in X1. This test method is suitable for determination of the extractable residue in metallic medical components. This practice proposes how to approach the identification of critical compounds and ast, different analytical methods. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

It identifies one technique to quantify extractable residue on metallic medical components. No other units of measurement are included in this standard. Residues may also cause harm at locations away from the implant. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.