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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This test method is also not intended to extract residue for use in biocompatibility testing. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO In addition, it is recognized that this test method may not be f245 only method to determine and quantify extractables.

It identifies one technique to quantify extractable residue on metallic medical components. There were no books found for the applied search filters.

This test method is suitable for determination of the extractable residue in metallic medical components. No other units of measurement are included in this standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. 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. No items in cart. All residues cannot necessarily be detected. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances.

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

Link to Active This link will always route to the current Active version of the standard. Residues may also cause harm at locations away from the implant. 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 the safety concerns, if any, associated with its use.

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Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Historical Version s – view previous versions of standard. Historical Version s – view previous versions of standard.

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. Asm residue includes aqueous and non-aqueous residue, as well as non-soluble residue. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Residues may induce no tissue response, minor tissue irritations, or they may lead to local zstm of tissues surrounding the xstm which may lead to failure in short-term or long-term use.

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No other units of measurement are included in this standard. Remember me for one month.

ASTM F2459 – 18

It identifies two techniques to quantify extractable residue on metallic medical components. For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO This standard does not purport to address all of the safety concerns, if any, associated with its use. Register for a trial account. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM-F, –

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. No other units of measurement f24459 included in this standard. 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.