ASTM_F_619_-_14.pdf

Designation:F61914Standard Practice forExtraction of Medical Plastics1This standard is issued under the fixed designation F619;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers methods of extraction of medicalplastics and may be applicable to other materials.This practiceidentifies a method for obtaining“extract liquid”for use indetermining the biological response in preclinical testing.Further testing of the“extract liquid”is specified in otherASTM standards.The extract may undergo chemical analysisas part of the preclinical evaluation of the biological response,and the material after extraction may also be examined.1.2 This practice may be used for,but is not limited to thefollowing areas:partial evaluation of raw materials,auditingmaterials within the manufacturing process,and testing finalproducts.This practice may also be used as a referee methodfor the measurement of extractables in plastics used in medicaldevices.1.3 This practice was initially developed for extraction ofmedical plastics not intended to undergo degradation or ab-sorption during normal medical device usage.When applied tothe extraction of absorbable materials,additional consider-ations may be necessary in the selection of extraction proce-dures and fluids.1.4 The values stated in inch-pound units are to be regardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.1.5 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:2D543 Practices for Evaluating the Resistance of Plastics toChemical ReagentsD570 Test Method for Water Absorption of PlasticsD1193 Specification for Reagent WaterD1239 Test Method for Resistance of Plastic Films toExtraction by ChemicalsD1898 Practice for Sampling of Plastics(Withdrawn 1998)3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Other Documents:USP NF 24 or current edition43.Definitions3.1 extraction vehiclea liquid specified for use in testingthe plastic.Specific extraction vehicles are to be designated bythe ASTM standard that references this practice(see Section 7for a list of standard extraction vehicles).3.2 extract liquidthat liquid which,after extraction of thespecimen,is used in tests.3.3 specimen portionthe unit or units of plastic placed intothe extraction vehicle.3.4 blankthe extraction vehicle not containing the speci-men under test which is used for comparison with the extractliquid.4.Summary of Practice4.1 Standard-size specimens of the plastic,which mayclosely simulate the intended device depending upon the use,are immersed in defined volumes of selected liquids(extractionvehicles)for the time and temperature specified.4.2 Achoice is made,based on the end use,of the extractionvehicles(see Section 7)and one of the combinations of timeand temperature for the test(see Section 12).4.3 The resultant test liquids(extract liquids)are kept insuitable containers as described in 6.3 until used for testing.The test liquids shall be stored tightly stoppered at normalroom temperature.Test liquids for biological testing are kept in1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.16 on Biocompatibility Test Methods.Current edition approved March 1,2014.Published April 2014.Originallyapproved in 1979.Last previous edition approved in 2008 as F619 03(2008).DOI:10.1520/F0619-14.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 sterile containers.Consideration should be given as to whetherthe extraction should be done under aseptic conditions.The testliquids for biological testing should be used within 24 h.5.Significance and Use5.1 These extraction procedures are the initial part ofseveral test procedures used in the biocompatibility screeningof plastics used in medical devices.5.2 The limitations of the results obtained from this practiceshould be recognized.The