Site Overlay

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.

Author: Aragami Yomuro
Country: Venezuela
Language: English (Spanish)
Genre: Travel
Published (Last): 19 January 2013
Pages: 280
PDF File Size: 11.36 Mb
ePub File Size: 2.61 Mb
ISBN: 569-3-31439-390-8
Downloads: 93050
Price: Free* [*Free Regsitration Required]
Uploader: Akinom

For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — This test method is also not intended to extract residue for atsm in biocompatibility testing.

All residues cannot necessarily be detected. Active view current version of 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 d2459 packaging 1- 3. Note 1For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO In addition, it is recognized that this test method may not be the only method to determine and quantify aastm.

It identifies two techniques to quantify extractable residue on metallic medical components. Residues may induce no tissue response, minor tissue 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. Significance and Use This test method is suitable for determination of the extractable residue in metallic medical components. This standard does not purport to address all of the safety concerns, if any, associated with its use.

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

  EL PLACER DE LEER Y ESCRIBIR IRMA BALLESTER PDF

If you like to setup a quick demo, let us know at support madcad. There were no books found for the applied search filters. 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.

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. Are you sure you want to empty astn cart? Work Item s – proposed revisions of this standard. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables.

Click here to download full list of books.

ASTM-F, –

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

Copyright Compu-tecture, Inc. In particular, it does not address substances released during implant resorption, implant coatings, or leachables by design. Please login to your authorized staff account to use this feature. No items in cart. This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component SUD.

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 test method recommends the use of a sonication technique to extract residue from the medical component.

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

  HORTUS DELICIARUM PDF

This practice may also be used to characterize semi-finished components for implants. Residues may also cause harm at locations away from the implant. Note 1—For extraction of samples intended for the biological evaluation of devices or materials, refer to ISO — 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. Historical Version s – view previous versions of standard. Today, some 12, ASTM aastm are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. FORMAT Single User Subscription Site License Subscription Astmm All Books Adtm All Packages EDITION to PUBLISHER.

ASTM F2459 – 18

This test method is also not intended to extract residue for use in biocompatibility testing. It suggests standard techniques that may be applied for analysis, and provides suggestions for how limit values may be set.

Register for a trial account. Astmm Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. This practice does not suggest or recommend test methods for biocompatibility, which may be found in Practice F or in ISO