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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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.

Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components. This standard does not purport to address all of ast, 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.

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

ASTM-F, –

Land Use and Development. Work Item s – proposed revisions of this standard. This test method is also not intended to extract residue for use in biocompatibility testing.

Click here to download full list of f249. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO Residues may also cause harm at locations away from the implant. Link to Active This link will always route to the current Active version of the standard.

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This test method is also not intended to extract residue for use in biocompatibility testing. Print 1 2 3 4 5 page sstarting from page current page.

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. 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. It identifies two techniques to quantify extractable residue on metallic medical components.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. There were no books found for the applied search filters.

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ASTM F2459 – 18

This practice may also be used to characterize semi-finished components for implants. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. No other units of measurement are included in this standard. Copyright Compu-tecture, Inc.

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. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

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New ASTM F Standard Test Method for Extracting Residue

This test method is suitable for determination of the extractable residue in metallic medical components. For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Please login to your authorized staff account to use this feature.

FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. 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.

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. Referenced Documents purchase separately The documents listed below are referenced within ashm subject standard but are not provided as part of the standard.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.