ASTM_F_2459_-_12.pdf

Designation:F245912Standard Test Method forExtracting Residue from Metallic Medical Components andQuantifying via Gravimetric Analysis1This standard is issued under the fixed designation F2459;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers the quantitative assessment ofthe amount of residue obtained from metallic medical compo-nents when extracted with aqueous or organic solvents.1.2 This test method does not advocate an acceptable levelof cleanliness.It identifies one technique to quantify extract-able residue 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.NOTE1For extraction of samples intended for the biological evalu-ation of devices or materials,refer to ISO 1099312.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.7 Thisstandardmayinvolvehazardousorenvironmentally-restricted materials,operations,and equip-ment.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 appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodG121 Practice for Preparation of Contaminated Test Cou-pons for the Evaluation of Cleaning AgentsG131 Practice for Cleaning of Materials and Components byUltrasonic TechniquesG136 Practice for Determination of Soluble Residual Con-taminants in Materials by Ultrasonic Extraction2.2 ISO Standard:3ISO 1099312 Biological EvaluationSample Preparationand Reference Materials3.Terminology3.1 Definitions:3.1.1 ionic compounds/water soluble residueresidue thatis soluble in water,including surfactants and salts.3.1.2 non-soluble debrisresidue including metals,organicsolids,inorganic solids,and ceramics.3.1.3 non-water soluble residueresidue soluble in solventsother than water.Inclusive in this are oils,greases,hydrocarbons,and low molecular weight polymers.Typicalsolvents used to dissolve these residues include chlorinated orfluorinated solvents,or low molecular weight hydrocarbons.3.1.4 reflux systeman apparatus containing an extractionvessel and a solvent return system.It is designed to allowboiling of the solvent in the extraction vessel and to return anyvaporized solvent to the extraction vessel.3.1.5 reusethe repeated or multiple use of any medicalcomponent(whether labeled SUD or reusable)with reprocess-ing(cleaning,disinfection,or sterilization,or combinationthereof)between patient uses.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved March 1,2012.Published March 2012.Originallyapproved in 2005.Last previous edition approved in 2005 as F2459 05.DOI:10.1520/F2459-12.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.6 single use component(SUD)a disposable compo-nent;intended to be used on one patient during a singleprocedure.3.1.7 surface areathe projected surface area of a part.Thisarea does not include the internal porosity of parts withcancellous,porous,or wire structure.3.2 Symbols:m1=weight of extraction vessel and component beforeextractionm2=weight of extraction vessel,component,foil,andsolvent after extractionm3=mass of clean beaker and foil used to hold removedaliquot of extracte