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 practice may also be used to characterize semi-finished components for implants. This standard does not purport to address all of the safety concerns, if any, asstm with its use.

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

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. This practice does not suggest or recommend test methods f24459 biocompatibility, which may be found in Practice F or in ISO Other techniques, f259 as solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1.

No items in cart. Register for a trial account. 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. Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO 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.

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Search book title Enter keywords for book title search. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. Print 1 2 3 4 5 page sstarting from page current page. Link to Active This link will always route to the current Active version of the standard.

FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances.

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

ASTM-F, –

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

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.

Residues may also cause harm at locations away from the implant. 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.

This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.

Remember me for one month. Please login to your authorized staff account to use this feature. No other units of measurement are included in this standard. Work Item s – proposed revisions of this standard.

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ASTM F2459 – 18

Significance and Use 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 aetm, refer to F2549 — Click here to download full list of books.

This test method is also not intended to extract residue for use in biocompatibility testing. Copyright Compu-tecture, Inc. Link to Active Astn link will always route to the current Active version of the standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 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.

Work Item s – proposed revisions of 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.

This test method recommends the use of a sonication technique to extract residue from the medical component. This standard asttm not purport to address all of the safety concerns, if atm, associated with its use. This test method is also not intended to extract residue for use in biocompatibility testing.