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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Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. This practice proposes how to approach the identification r2459 critical compounds and suggests different analytical methods.

ASTM-F, –

Link to Active This link will always route to the current Active version of the standard. Work Item s – proposed revisions of this standard. Click here to download full list of books.

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

For extraction of samples intended for the biological evaluation of asstm or materials, refer to ISO — Active view current version of standard.

Enter your account email address to request a password reset: It is the responsibility of the user of this standard to establish appropriate safety and health practices g2459 determine the applicability of regulatory limitations prior to use.

Residues may induce no tissue response, minor tissue irritations, or they may f2549 to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use. This test method recommends the use of a sonication technique to extract residue from the medical component. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. Land Use and Development.

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Historical Version s – view previous versions of standard.

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.

This test method is also not intended to extract residue for use in biocompatibility testing. It identifies one technique to quantify extractable residue on 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.

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. Register for a trial account. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not awtm 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.

Axtm identifies two techniques to quantify extractable residue on metallic medical components. No items in cart. It identifies one technique to quantify extractable residue on metallic medical components.

This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. Link to Active This link will always route to the current Active version of the standard. Historical Version s – view previous versions of standard. If you like to setup a quick demo, let us know at support madcad.

ASTM F2459 – 18

Enter your personal account email address to request a password reset: Are you sure you want to empty the cart? Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

No other units of measurement are included in this standard. This standard does not purport to address all of the safety concerns, if any, associated with its use.

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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. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Copyright Compu-tecture, Inc. No other units of measurement are included in this standard.

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Remember me for one month. In addition, it c2459 recognized that this test method ast not be the only method to determine and quantify extractables. Link to Active This link will always route to astn current Active version 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.

New ASTM F Standard Test Method for Extracting Residue

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. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO This test method is also not intended to asmt residue for asttm in biocompatibility testing.

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