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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ASTM F2459 – 18

Register for a trial account. For extraction of samples intended for the biological evaluation of asmt or materials, refer to ISO — This practice may also be used to characterize semi-finished components for implants. It identifies two techniques to quantify extractable residue on metallic medical components. It identifies one technique to quantify extractable residue on metallic medical components.

No other units of measurement are included in this standard. It identifies one technique to quantify extractable residue on metallic medical components. Search book title Enter keywords for book title search. Other techniques, such as solvent reflux extraction, could be used asym 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. No other units of measurement are included in this standard. Remember me for one month. Significance and Use This asrm method is suitable for determination of the extractable residue in metallic medical components. 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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Note 1For 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.

It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the xstm of regulatory limitations prior to use. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Please login to your authorized staff account to use this feature. 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.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. There were no books found for the applied search filters. Link to Active This link will astk route to the current Active version of the standard. Other techniques, such asrm solvent reflux extraction, could be used but have been shown to be less efficient in some tests, as discussed in X1. 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. Click here to download full list of books. Enter your account email address to request a password reset: FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. Work Item s – proposed revisions of this standard. 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.

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New ASTM F Standard Test Method for Extracting Residue

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

No items in cart. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically held f249, efflorescence, or mechanically held substances.

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

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