ASTM_F_639_-_09_2015.pdf

Designation:F63909(Reapproved 2015)Standard Specification forPolyethylene Plastics for Medical Applications1This standard is issued under the fixed designation F639;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 specification covers polyethylene plastics(as de-fined in Terminology D883)intended for use in medical deviceapplications involving human tissue contact devices,short-term indwellings of 30 days or less,and fluid transfer devices.The biocompatibility of these materials as a class has not beenestablished.Biocompatibility tests must be conducted on thefinal product.1.2 This specification is not applicable to ultra-high molecu-lar weight polyethylenes(UHMWPE)plastics,such as thoseused in joint implants,and so forth.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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for Tensile Properties of PlasticsD671 Test Method for Flexural Fatigue of Plastics byConstant-Amplitude-of-Force(Withdrawn 2002)3D695 Test Method for Compressive Properties of RigidPlasticsD747 Test Method for Apparent Bending Modulus of Plas-tics by Means of a Cantilever BeamD790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-alsD883 Terminology Relating to PlasticsD1238 Test Method for Melt Flow Rates of Thermoplasticsby Extrusion PlastometerD1505 Test Method for Density of Plastics by the Density-Gradient TechniqueD1898 Practice for Sampling of Plastics(Withdrawn 1998)3D4976 Specification for Polyethylene Plastics Molding andExtrusion MaterialsE117 Method for SpectrographicAnalysis of Pig Lead by thePoint-to-Plane Technique(Withdrawn 1995)3F748 Practice for Selecting Generic Biological Test Methodsfor Materials and Devices2.2 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices43.Significance3.1 This specification describes polyethylene plastics usedin the manufacture of medical devices or components ofmedical devices.The properties listed should be considered inselecting material according to the specific end-use require-ments.4.Classification4.1 Types of polyethylene plastics molding and extrusionmaterial are described in Specification D4976.5.General Requirements5.1 Polyethylene plastics consist of basic polymers madewith ethylene as essentially the sole monomer(as defined inTerminology D883).5.2 Polyethylene for use in medical applications shall havea maximum extractable fraction,expressed as weight percentin polymer,in n-hexane of 5.5%at 50C.55.3 The formulated compound may contain optional adju-vant substances required in the production of the polymer or inthe fabrication or intended use of the end product.Thebiocompatibility of these adjuvant substances shall be estab-lished on the finished compound(see Section 9).1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved March 1,2015.Published May 2015.Originallyapproved in 1979.Last previous edition approved in 2009 as F639 09.DOI:10.1520/F0639-09R15.2For 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.5Federal Register,Vol 21,Part 177.1520.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.4 The formulated compound shall yield a consistent in-frared absorption spectrum characteristic of the establishedformulation.5.5 Maximum levels and type of extractable metals shall beestablished in accordance with the intended use of the formu-lated resin6(see Appendix X1).NOTE1Appendix X1 is a suggested method for determining extract-able metals utilizing the current state-of-the-art methodology.Alternativemethods with equal reliability may be used.5.6 The physical properties of polyethylene plastics may bedetermined by the methods given in Section 7.6.Sampling6.1 The material should be sampled in accordance withstandard sampling procedures such as those described in