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

It identifies two qstm to quantify extractable residue on metallic medical components.

ASTM-F, –

This standard does not purport to address f245 of the safety concerns, if any, associated with its use. No items in cart. Astn to Active This link will always route to the current Active version of the standard. Historical Version s – view previous versions of standard. This test method is also not intended to extract residue for use in biocompatibility testing. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — This test method is also not intended to extract residue for use in biocompatibility testing.

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Please login to your authorized staff account g2459 use this feature. This test method is suitable for determination of the extractable residue in metallic medical components. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD.

Are you sure you want to empty the cart? Copyright Compu-tecture, Inc. Enter your personal account email address to request a password reset: This standard does not purport to address all of the safety concerns, if any, associated with its use. There were no books found for the applied search filters.

ASTM F2459 – 18

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

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. In addition, it is recognized that this test method may not be the only method to determine and quantify f245. For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

Significance and Use This test sstm is suitable for determination of the extractable residue in metallic medical components. Register for a trial account. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO Click here to download full list of books.

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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. Historical Version s – view previous versions of standard.

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. F24559 Use and D2459.

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. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances. Residues may also cause harm at locations away from the implant. Print 1 2 3 4 5 page sstarting from page current page.

Note 1For extraction of samples intended for the f2549 evaluation of devices or materials, refer to ISO 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. Work Item s – proposed revisions of this standard. It identifies one technique to quantify extractable residue on metallic medical components.