ASTM_F_1635_-_11.pdf

Designation:F163511Standard Test Method forin vitro Degradation Testing of Hydrolytically DegradablePolymer Resins and Fabricated Forms for SurgicalImplants1This standard is issued under the fixed designation F1635;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 in vitro degradation of hydro-lytically degradable polymers(HDP)intended for use insurgical implants.1.2 The requirements of this test method apply to HDPs invarious forms:1.2.1 Virgin polymer resins,or1.2.2 Any form fabricated from virgin polymer such as asemi-finished component of a finished product,a finishedproduct,which may include packaged and sterilized implants,or a specially fabricated test specimen.1.3 This test method provides guidance for mechanicalloading or fluid flow,or both,when relevant to the device beingevaluated.The specifics of loading type,magnitude,andfrequency for a given application are beyond the scope of thistest method.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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:2D638 Test Method for Tensile Properties of PlasticsD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force(Withdrawn 2002)3D695 Test Method for Compressive Properties of RigidPlasticsD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsD882 Test Method for Tensile Properties of Thin PlasticSheetingD1708 Test Method for Tensile Properties of Plastics by Useof Microtensile SpecimensD1822 Test Method for Tensile-Impact Energy to BreakPlastics and Electrical Insulating MaterialsD2857 Practice for Dilute Solution Viscosity of PolymersF748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 Other Referenced Standard:ISO 318 Physical Chemistry and Molecular Physics-Part8:Quantities and UnitsISO 109931 Biological Evaluation of Medical DevicesPart 1 Evaluation and Testing4ISO 109939 Biological Evaluation of Medical DevicesPart 9 Framework for Identification and Quantification ofPotential Degradation Products4NIST Special Publication SP811 Guide for the Use of theInternational System of Units(SI)53.Terminology3.1 Definitions:3.1.1 absorbable,adjin the bodyan initially distinctforeign material or substance that either directly or throughintended degradation can pass through or be assimilated bycells and/or tissue.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved March 1,2011.Published March 2011.Originallyapproved in 1995.Last previous edition approved in 2004 as F1635 04a.DOI:10.1520/F1635-11.2For 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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.5Available from National Institute of Standards and Technology(NIST),100Bureau Dr.,Stop 1070,Gaithersburg,MD 20899-1070,at http:/physics.nist.gov/cuu/Units/bibliography.html.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 NOTE1See Appendix X2 for a discussion regarding the usage ofabsorbable and other related terms.3.1.2 hydrolytically degradable polymer(HDP)any poly-meric material in which the primary mechanism of chemicaldegradation in the body is by hydrolysis(water reacting withthe polymer resulting in cleavage of the chain).3.1.3 resinany polymer that is a basic material for plas-tics.64.Summary of Test Method4.1 Samples of polymer resins,semi-finished components,finished surgical implants,or specially designed test specimensfabricated from those resins are placed in buffered salinesolution at physiologic temperatures.Samples are periodicallyremoved and tested for various material or mechanical prop-erties at specified intervals.The required test intervals varygreatly depending on the specific polymeric composition.Forexample,poly(l-lactide)and poly(e-capr