January 19, 2019

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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This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.

Are you sure you want to empty the cart? 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. This standard does not purport to address all of the safety concerns, if any, associated with its use.

Note 1—For extraction of samples intended for the biological evaluation of devices or f245, refer to ISO — This test method is suitable for determination of the extractable residue in metallic medical components. Active view current version of standard.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. Work Item s – proposed revisions of this standard. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Please login to your authorized staff account to aastm 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 induce no tissue aetm, minor aztm 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. No other units of measurement are included in this 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.

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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. Remember me for one month. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates.

This standard does not purport to address all of the safety concerns, if any, associated with its use. There were no books found for the applied search filters. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. No other units of measurement are included in this standard. If you like to setup a quick demo, let us know at support madcad. All residues cannot necessarily be detected. This test method is also not intended to extract residue for use in biocompatibility testing.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. 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. Search book title Enter keywords for book title search.

Enter your account email address to request a password reset: Historical Version s – view previous versions of standard. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.

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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. Click here to download full list of books.

ASTM F2459 – 18

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Land Use and Development. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages Aetm to PUBLISHER. No items in cart. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD.

It is the responsibility of the aastm of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

It is f259 responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the r2459 of regulatory limitations prior to use. It identifies two techniques to quantify extractable residue on metallic medical components. It identifies one technique to quantify extractable residue on metallic medical components.

Link to Active This link will always route to the current Active version of the standard. Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO This practice may also be used to characterize semi-finished components for implants.