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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Please login to your authorized staff account to use this feature. Residues may be soluble in aqueous media, soluble in organic solvents, or may be insoluble particulates. Link to Active This link will always route awtm the current Active version of the standard. Remember me for one month.

This test method is also not intended to extract residue for use in biocompatibility testing. Asym addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Referenced Documents purchase separately The documents listed below are referenced within the subject 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.

They may exhibit as surface-bound substance, or as adsorbates for example, electrostatically heldefflorescence, or mechanically held substances. 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.

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 suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set. No items in cart.

ASTM F2459 – 18

Land Use and Development. 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 1For extraction of xstm intended for the biological evaluation of devices or materials, refer to ISO If you like to setup a quick demo, let us know at support madcad.

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Significance and Use This test method asgm suitable for determination of the extractable residue in metallic medical components. Residues may also cause harm at locations away from the implant. This standard does not purport to address all of the safety concerns, if any, associated with its use.

Are you sure you want to empty the cart? This test method is also not intended to extract residue for use in biocompatibility testing. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

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.

New ASTM F Standard Test Method for Extracting Residue

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Enter your account email address to request a password reset: Historical Version s – view previous versions of standard. Link to Active This link will always route to the current Active version of the standard.

Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods. In addition, it is recognized that this test method may f2495 be the only method to determine and quantify extractables.

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 materials, refer to ISO — There were no books found for the applied search filters.

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No other units of measurement are included in this standard. No other units of measurement are included in this standard. This test method is suitable for determination of the extractable residue in metallic medical components. For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — Work Item s – proposed revisions of 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. This practice may also be used to characterize semi-finished components for implants.

It identifies one technique to quantify extractable residue on metallic medical components. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of f245 limitations prior to use.

ASTM-F, –

Print 1 2 3 4 5 page sstarting from page current page. Copyright Compu-tecture, Inc. Link to Active This link will 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. Search book title Enter keywords for book title search.

Register for a trial account. No other units of measurement are included in this standard. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO It identifies one technique to quantify extractable residue on metallic medical components.

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