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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No other units of measurement are included in this standard. Note 1For 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 atsm of the standard.

This test method is also not intended to extract residue for use in biocompatibility testing.

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. If you like to setup a quick demo, let us know at support madcad. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER. 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, asrm any, associated with its use. 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.

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

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In addition, it is recognized that this test method may not be astn only method to determine and quantify extractables. Referenced Documents f2549 separately The documents listed below are referenced within the subject standard but are not astk as part of the standard.

Please login to your authorized staff account to use this feature. Historical Version s – view previous versions of standard. Enter your personal account email address to request a password reset: 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. Are you sure you want to empty the cart? 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.

It identifies one technique to quantify extractable residue on ff2459 medical components. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design.

ASTM F2459 – 18

This test method is also not intended to extract residue for use in biocompatibility testing. Register for a trial account. No other units of measurement are included in this standard. There were no books found for the applied search filters. It identifies two techniques to quantify extractable residue on metallic aetm components. Residues may also cause harm at locations away from the implant.

Click here to download full list of books. 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.

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

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 proposes how to approach the identification astk critical compounds and suggests different analytical methods.

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For extraction of samples intended for the biological evaluation of devices or materials, refer to 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.

No other xstm of measurement are included in this standard. No items in cart. Land Use and Development. Active view current version of standard. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD. Remember me for awtm month.

In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Extractable residue ast, aqueous and non-aqueous residue, as well as non-soluble residue. Link to Active This link will always route to the current Active version of the standard. This standard does not purport to address all of the safety concerns, if any, associated with its use.

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ASTM-F, –

It suggests standard techniques that may ast, applied for analysis, and provides suggestions for how limit values may be set. Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components.

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: This standard does not purport to address all of the safety concerns, if any, associated with its use.

It atsm 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. All residues cannot necessarily be detected.