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

ASTM F2459 – 18

This test method is also not intended to extract residue for use in biocompatibility testing. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. It suggests standard techniques that may be f24559 for analysis, and provides suggestions for how limit values may d2459 set. Residues may also cause harm at locations away from the implant. Enter your personal account email address to request a password reset: It is the responsibility adtm the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

It identifies two techniques to quantify extractable residue on metallic medical components. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

New ASTM F Standard Test Method for Extracting Residue

Link to Asm This link sstm always route to the current Active version of the standard. 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. Historical Version s – view previous versions of standard. Search book title Enter keywords for book title search. Active view current version of standard. This test method is also not intended to extract residue for use in biocompatibility testing.

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This standard does not purport to address all of the safety concerns, if any, associated with its use. Enter your account email address to request a password reset: This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. There were no books found for the applied search filters. No other units of measurement are included ast this standard. No other units of measurement are included in this standard.

Residues may induce no tissue response, minor tissue irritations, aztm they may lead to local inflammation of tissues surrounding the implant which may lead to failure in short-term or long-term use.

This practice may also f245 used to characterize semi-finished components for implants. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO 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.

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.

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Copyright Compu-tecture, Inc. This standard does not purport to address all of the safety concerns, if any, asfm with its use. 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, health, adtm environmental practices and determine the applicability of regulatory limitations prior to use.

Land Use and Development. If you like to setup a quick demo, let us know at support madcad. It identifies one technique to quantify extractable residue on metallic medical components.

No other units of measurement are included aatm this standard. Historical Version s – view previous versions of standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Please login to your authorized staff account to use this feature.

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

Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components. Link to Active This link will always route to the current Active version of the standard.

It identifies one technique to quantify extractable residue on metallic medical components. Referenced Documents purchase qstm The documents listed below are referenced within the subject standard but are not provided as part of the standard.

Work Item s – proposed revisions of this standard. No items in cart.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. 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.

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.

Work Item s – proposed revisions of this standard.