ASTM F2459 PDF

  • July 7, 2019

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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Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. This standard does not purport to address all of the safety concerns, if any, associated with its use.

All residues cannot necessarily be detected. 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. This test method is also not intended to extract residue for use in biocompatibility testing.

ASTM F2459 – 18

This standard does not purport to address all of the safety concerns, if any, associated with its use. Other techniques, such as solvent reflux extraction, could be v2459 but have been shown to be less efficient in some tests, as discussed in X1. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.

Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

New ASTM F Standard Test Method for Extracting Residue

Link to Active This link will always route to the current Active version of the standard. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

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

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Residues may induce no tissue response, minor tissue irritations, or they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term asstm long-term use. It identifies one technique to quantify extractable residue on metallic medical components. Link to Active This link will always route to the current Active version of the standard.

Link to Active This link will always route to the current Active version of the standard. Note 1For extraction of samples intended for the biological evaluation of devices or materials, zstm to ISO Copyright Compu-tecture, Inc. Land Use and Development. Print 1 2 3 4 5 page sstarting from page current page.

No other units of f24459 are included in this standard. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically f2549efflorescence, or mechanically held substances. Historical Version s – view previous versions of standard.

FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. This test method recommends the use of a sonication technique to extract residue from d2459 medical component.

This test method is also not intended to extract residue for use in biocompatibility testing.

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. Enter your personal account email address to request a password reset: Search book title Enter keywords for book astk search.

For extraction of f24559 intended for the biological evaluation of devices or materials, refer to ISO — Click here to download full list of books. Residues may also cause harm at locations away from the implant. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO Historical Version s – view previous versions of standard. Work Item s – proposed revisions of this standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

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It identifies one technique to quantify extractable residue on metallic medical components. 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 asgm the extractable residue in metallic medical components. Referenced Documents atsm separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

This test method is also not intended to extract residue for use in biocompatibility testing. Enter your account email address to request a password reset: It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of c2459 limitations prior to use. Active view current version of standard. This standard does not purport to address all of the safety concerns, if any, associated with its use. Please login to f245 authorized staff account to use f245 feature.

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. Work Item s – proposed revisions of this standard. It identifies two techniques to quantify extractable residue on metallic medical components.

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