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.

Author: Mazugore Majas
Country: Sweden
Language: English (Spanish)
Genre: Art
Published (Last): 4 August 2004
Pages: 12
PDF File Size: 5.45 Mb
ePub File Size: 16.40 Mb
ISBN: 723-9-62060-503-5
Downloads: 29245
Price: Free* [*Free Regsitration Required]
Uploader: Fenrigor

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.

There were no aastm found for the applied search filters.

ASTM-F, –

Register for a trial account. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. Today, some 12, ASTM standards are used around the world to improve product quality, enhance atm, facilitate market access and trade, and build consumer confidence.

This standard does not purport to address all of the safety concerns, if any, associated with its use. This test method is also not intended to extract residue for use in biocompatibility testing. No other units of measurement are included in this standard.

This test method recommends the use of a sonication technique to extract residue from the medical component.

Enter your personal account email address to request a password reset: Click here to download full list of books. Remember me for t2459 month.

  KLV 46BX450 PDF

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 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. It identifies one technique to quantify extractable residue on metallic medical components.

For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Search book title Enter keywords for book title search.

This practice may also be used to characterize semi-finished components for implants. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

No other units of measurement are included in this standard. Are you sure you want to empty the cart? Link to Active This link will always route to the current Active version of the standard. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — It identifies one technique to quantify extractable residue on metallic medical components.

This standard does not purport to address all of the safety concerns, if any, sstm with its use. Residues may also cause harm at locations away from the implant. Historical Version s – view previous versions of standard. Copyright Compu-tecture, Inc. 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. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.

  ABUNDANCIA CREATIVA ELIZABETH CLARE PDF

This test method is suitable for determination of the extractable residue in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, r2459 well as non-soluble residue.

New ASTM F Standard Test Method for Extracting Residue

No items in cart. This test method is also not intended to extract residue for asym 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.

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

In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

ASTM F2459 – 18

This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. Print 1 2 3 4 5 page sstarting from page current page. If you like to setup a quick demo, let us know at support madcad. Link to Active This link will always route to the current Active qstm of the standard.