ASTM F2459 PDF

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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.

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

F2549 test method is also not intended to extract residue for use in biocompatibility testing.

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. Land Use and Development. Work Item s – proposed revisions of this standard. Copyright Compu-tecture, Inc. Are you sure you want to empty the cart?

This test method recommends the use of a sonication technique to extract residue from the medical component. Enter your account email address to request a password reset: Link to Active This link will always route to the current Active version of the standard. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. It identifies two techniques to quantify extractable residue on metallic medical components.

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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 extractables. 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. 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.

Active view current version of standard. Please login to your authorized staff account to use this feature. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO Significance and Use 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.

ASTM F2459 – 18

This standard does not purport to address all of the safety concerns, if any, associated with its use. Search book title Enter keywords for book title search. For extraction of samples g2459 for the biological evaluation of devices or materials, refer to ISO — No other units of measurement are included in this standard.

This test method is also not intended to extract ast for use in biocompatibility testing. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. Remember me for one month. 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. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

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Historical Version s – view previous versions of standard. Referenced Documents purchase separately The documents listed atm are referenced within the subject standard but are not provided as part of the standard.

Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.

New ASTM F Standard Test Method for Extracting Residue

This practice may also be used to characterize semi-finished components for implants. It is the responsibility of the user of this standard to establish appropriate safety, health, and f259 practices and determine the applicability of regulatory limitations prior to use.

Click here to download full list of books. 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.

It identifies one technique to quantify extractable residue on metallic medical components. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. 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.

It identifies one technique to quantify extractable residue on metallic medical components. Work Item s – proposed revisions of this standard.