ASTM_F_1251_-_89_2003.pdf

Designation:F 1251 89(Reapproved 2003)Standard Terminology Relating toPolymeric Biomaterials in Medical and Surgical Devices1This standard is issued under the fixed designation F 1251;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(e)indicates an editorial change since the last revision or reapproval.1.Scope1.1 This terminology covers polymeric biomaterials inmedical and surgical devices.Terms are defined as they areused relative to medical and surgical materials and devices.Terms that are generally understood and in common usage oradequately defined in other readily available references are notincluded except where particular delineation to biomaterialsmay be more clearly stated.1.2 This terminology is therefore intended to be selective ofterms used generally in materials science and technology andpublished in a number of documents,such as those listed in thesucceeding sections.The listing is also intended to define termsthat appear prominently within other ASTM standards and donot appear elsewhere.1.3 The definitions are substantially identical to those pub-lished in other ASTM standards on metals,ceramics and glass,rubbers and polymers,and so forth,or published by otherstandards writing organizations,such as International Stan-dards Organization(ISO),American Institute of MechanicalEngineers(AIME),American Society of Plastic and Recon-structive Surgeons(ASPR),and Tissue Culture Association(TCA).1.4 Aneed exists for this terminology to supplement currentdocuments on terminology which concentrate on materials.This terminology covers each of the following disciplines:plastics(polymers),rubber(elastomers),and textiles(polymerderived).1.5 An increasing number of product(polymeric,metallur-gical,and ceramic types)designations and designations forchemical,physical,mechanical,and analytical tests and stan-dards are coming into common usage in the literature andcommerce of biomaterials in medical and surgical devices andclinical services.Section 2 lists those documents referenced inthis terminology.1.6 Table 1 lists abbreviated,anagramic designations.An-nex A1 is a thesaurus of general usage terms relating tobiomaterials.2.Referenced Documents2.1 ASTM Standards:D 638 Test Method for Tensile Properties of Plastics2D 747 Test Method for Apparent Bending Modulus ofPlastics by Means of a Cantilever Beam2D 790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-als2D 882 Test Methods for Tensile Properties of Thin PlasticSheeting2D 1003 Test Method for Haze and Luminous Transmittanceof Transparent Plastics2SI 10 02 American National Standard for Use of theInternational System of Units(SI):The Modern MetricSystem33.Terminology3.1 Definitions:acetal plastic,na plastic based on polymers having apredominance of acetal linkages in the main chain.(See alsopolyoxymethylene.)D20acrylic plastic,na plastic based on polymers made withacrylic acid or a structural derivative of acrylic acid.D20addition polymerization,npolymerization in which mono-mers are linked together without the splitting off of water orother simple molecules and involves the opening of a doublebond.D20aging,nthe process of exposing materials to an environmentfor an interval of time.D20aging effect,na change in a material brought about byexposure of the material to an environment for an interval oftime.alkyd resin,na polyester convertible into a crosslinkedform;requiring a reactant of functionality higher than two,or having double bonds.D20apparent densitysee density,apparent.artificial weathering,nexposure of a material to laboratoryconditions that simulate outdoor weathering.DISCUSSIONExposure conditions may be cyclic,involving changes1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.11on Polymeric Materials.Current edition approved Apr.10,2003.Published May 2003.Originallyapproved in 1989.Last previous edition approved in 1995 as F 1251 89(1995).2Annual Book of ASTM Standards,Vol 08.01.3Excerpts in Related Material sections of all other volumes.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.in temperature,relative humidity,radiant energy,and many otherelements found in the atmosphere in various geographical areas.Thelaboratory exposure conditions are usually intensified beyond thoseencountered in actual out-door exposure to accelerate the effect.D20blister,nin sheet plastics,an imperfection,a rounded eleva-tion of the surface,with boundaries that may be more or lesssharply defined,somewhat resembling in shape a blister onthe human skin.D20block copolymer,nan essentially linear copolymer in whichthere are repeated sequences of polymeric segments ofdifferent c