ASTM_F_665_-_09_2015.pdf

Designation:F66509(Reapproved 2015)Standard Classification forVinyl Chloride Plastics Used in Biomedical Application1This standard is issued under the fixed designation F665;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 classification provides guidance to engineers andusers in the selection of practical vinyl chloride plastics formedical applications and further provides a method for speci-fying these materials by use of a simple line call-out designa-tion.This classification excludes vinyl chloride plastics used inlong-term implants.1.2 Use is made of a classification scheme based on thepremise that the composition of vinyl chloride plastics,copolymers,fillers,plasticizers,stabilizers,and other additivesin these systems can be arranged into characteristic materialdesignations.1.3 In all cases where the provisions of this classificationsystem would conflict with those of the detailed specificationfor a particular device,the latter shall take precedence.NOTE1For cases in which the vinyl chloride plastic may be used forpurposes where the requirements are too specific to be completelydescribed by this classification system,it is advisable for the purchaser toconsult the supplier to secure adjustment of the properties to suit the actualconditions to which the device is to be subjected.1.4 The biocompatibility of vinyl chloride plastics as a classof materials has not been established.Since many composi-tions and formulations fall under this class,it is essential thatthe fabricators/device manufacturers assure the safety andefficacy of the specific composition or formulation,in itsintended application,using state-of-the-art test methods.1.5 This classification is to assist the interface between thematerial supplier and the device manufacturer(fabricator)whopurchases a formulated vinyl chloride plastic for a component.For those device manufacturers(fabricators)who do their ownformulating,compounding,extrusion,molding,and so forth,this classification does not apply.1.6 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:2D149 Test Method for Dielectric Breakdown Voltage andDielectric Strength of Solid Electrical Insulating Materialsat Commercial Power FrequenciesD150 Test Methods for AC Loss Characteristics and Permit-tivity(Dielectric Constant)of Solid Electrical InsulationD257 Test Methods for DC Resistance or Conductance ofInsulating MaterialsD543 Practices for Evaluating the Resistance of Plastics toChemical ReagentsD570 Test Method for Water Absorption of PlasticsD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD882 Test Method for Tensile Properties of Thin PlasticSheetingD955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD2124 Test Method for Analysis of Components in Poly(Vi-nyl Chloride)Compounds Using an Infrared Spectropho-tometric TechniqueD2240 Test Method for Rubber PropertyDurometer Hard-nessF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)32.2 Other Standards:21 CFR Code of Federal Regulations42.3 ISO Standard:ISO 10993 Biological Evaluation of Medical Devices53.Terminology3.1 Definitions:1This classification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.11 on Polymeric Materials.Current edition approved March 1,2015.Published May 2015.Originallyapproved in 1980.Last previous edition approved in 2009 as F665 09.DOI:10.1520/F0665-09R15.2For 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 Superintendent of Documents,U.S.Government PrintingOffice,Washington,DC 20402.5Available 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 3.1.1 fillera relatively inert material added to a plastic tomodify its strength,permanence,working properties,or otherqualities,or to lower costs.3.1.2 plasticizera substance incorporated into a materialto increase its w