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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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Note 1—For extraction of samples d2459 for the biological evaluation of devices or materials, refer to ISO — Link to Active This link will always route to the current Active version of the standard. Historical Version s – view previous versions of standard. Work Item s – proposed revisions of this standard. This standard does not purport to address all of the safety concerns, if any, associated with its use.

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

No other units of measurement are included in this standard. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of f24459 standard.

ASTM F2459 – 18

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not f4259 as part of the standard. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice Asgm or in ISO No other units of measurement are included in this standard. This test method is also not intended to extract residue for use in biocompatibility testing. 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 and health practices and determine the applicability of regulatory limitations prior to 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.

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Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. For extraction of samples intended for the biological evaluation of devices awtm materials, refer to ISO — This test method is also not intended to extract residue for use in biocompatibility testing.

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

Aatm Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. Historical Version s – view previous versions of standard. Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components. Enter your account email address to request a password reset: In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

New ASTM F Standard Test Method for Extracting Residue

In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. Enter your personal account email address to request a password reset: 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.

Are you sure you want to empty the cart? Active view current version of standard.

ASTM-F, –

It identifies two techniques to quantify extractable residue on metallic medical components. Print 1 2 3 4 5 page sstarting from page current page. 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. This practice proposes how to f24459 the identification of critical compounds and suggests different analytical methods.

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Please login to your authorized qstm account to use this feature. 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 also cause harm at locations away from the implant. Click here to download full list of books. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

Referenced Documents purchase separately The documents listed below aetm referenced within the subject standard but are not provided as part of the standard. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. 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.

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. Link to Active This link will always route to the current Active version of the standard. Remember me for one month. This standard does not purport to address all of the safety concerns, if any, associated with its use.

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

It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. 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.