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ASTM F2459-2012 standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis

Standard Number:  ASTM F2459-2012
Title:  standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis
Language:  English
Replacing Standard:  ASTM F2459-05

Publication Date:  2012/3/1
Execute Date:  2012/3/1
Status:  Current
Publisher:  American Society for Testing Material (ASTM)
Price:  
Number of Pages:  

Description:1.1 this test method covers the quantitative assessment ofthe amount of residue obtained from metallic medical componentswhen extracted with aqueous or organic solvents.1.2 this test method does not advocate an acceptable levelof cleanliness. it identifies one technique to quantify extractableresidue on metallic medical components. in addition, it isrecognized that this test method may not be the only method todetermine and quantify extractables.1.3 although these methods may give the investigator ameans to compare the relative levels of component cleanliness,it is recognized that some forms of component residue may notbe accounted for by these methods.1.4 the applicability of these general gravimetric methodshave been demonstrated by many literature reports; however,the specific suitability for applications to all-metal medicalcomponents will be validated by an interlaboratory study (ils)conducted according to practice e691.1.5 this test method is not intended to evaluate the residuelevel in medical components that have been cleaned for reuse.this test method is also not intended to extract residue for usein biocompatibility testing.note 1—for extraction of samples intended for the biological evaluationof devices or materials, refer to iso 10993–12.1.6 the values stated in si units are to be regarded asstandard. no other units of measurement are included in thisstandard.1.7 this standard may involve hazardous orenvironmentally-restricted materials, operations, and equipment.this standard does not purport to address all of thesafety concerns, if any, associated with its use. it is theresponsibility of the user of this standard to establish appropriatesafety and health practices and determine the applicabilityof regulatory limitations prior to use.  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  228KB
Tile in English:  standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis

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