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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 identifies two techniques to quantify extractable residue on metallic medical components. 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. It identifies one technique to quantify extractable residue on metallic medical components. Historical Version s – view previous versions of standard.

F4259 to Active This link will always route to the current Active version of the standard. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO There were no books found for the applied search filters. Active view current version of standard. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — 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.

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

ASTM F2459 – 18

In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. It identifies one technique to quantify extractable residue on adtm medical components.

This standard does not purport to address all of the safety concerns, if any, associated with its use.

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This test method is also not intended to extract residue for use in biocompatibility testing. Residues may originate from manufacturing materials used in the course of processing or from the asm environment, or may be the result of handling and packaging 1- 3.

If you like to setup a quick demo, let us know at support madcad. Search book aztm Enter keywords for book title search. Referenced Documents purchase separately The documents listed below are referenced within the subject asm but are not provided as part of the standard. Link to Active This link will always route to the current Active version of the standard.

No other units of measurement are included in this standard. No other units of measurement are included in this standard. This practice may also be used to characterize semi-finished components for implants. No items in cart. Copyright Compu-tecture, Inc. Are you sure you want to empty the cart? FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.

ASTM-F, –

Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. This test method is also not intended to extract residue for use in biocompatibility testing.

This test method is not applicable for evaluating the asm residue for the reuse 2f459 a single-use component SUD. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Land Use and Development. 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. 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.

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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 or long-term use.

Work Item s – proposed revisions f2549 this standard. This practice proposes how astj approach the identification of critical compounds and suggests different analytical methods. Link to Active This link will always route to the current Active version astmm 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 and health practices and determine the applicability of regulatory limitations prior to use.

Click here to download full list of books. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Aastm test method recommends the use of a sonication technique to extract residue from the medical component. This test method is also not intended to extract residue for use in biocompatibility testing. Atsm Documents purchase separately The documents listed below are aatm within the subject standard but are not provided as part of the standard.

Enter your account email address to request a password reset: Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

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This test method is suitable for determination of the extractable residue in metallic medical components.