ASTM F1251-89(1995)
(Terminology)Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
SCOPE
1.1 This terminology covers polymeric biomaterials in medical and surgical devices. Terms are defined as they are used relative to medical and surgical materials and devices. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to biomaterials may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in materials science and technology and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published in other ASTM standards on metals, ceramics and glass, rubbers and polymers, etc., or published by other standards writing organizations, such as International Standards Organization (ISO), American Institute of Mechanical Engineers (AIME), American Society of Plastic and Reconstructive Surgeons (ASPR), and Tissue Culture Association (TCA).
1.4 A need exists for this terminology to supplement current documents on terminology which concentrate on materials. This terminology covers each of the following disciplines: plastics (polymers), rubber (elastomers), and textiles (polymer derived).
1.5 An increasing number of product (polymeric, metallurgical, and ceramic types) designations and designations for chemical, physical, mechanical, and analytical tests and standards are coming into common usage in the literature and commerce of biomaterials in medical and surgical devices and clinical services. Section 2 lists those documents referenced in this terminology.
1.6 Table 1 lists abbreviated, anagramic designations. Annex A1 is a thesaurus of general usage terms relating to biomaterials.
General Information
Relations
Standards Content (Sample)
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1251 – 89 (Reapproved 1995)
Standard Terminology Relating to
Polymeric Biomaterials in Medical and Surgical Devices
This standard is issued under the fixed designation F 1251; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This terminology covers polymeric biomaterials in 2.1 ASTM Standards:
medical and surgical devices. Terms are defined as they are D 638 Test Method for Tensile Properties of Plastics
used relative to medical and surgical materials and devices. D 747 Test Method for Apparent Bending Modulus of
Terms that are generally understood and in common usage or Plastics by Means of a Cantilever Beam
adequately defined in other readily available references are not D 790 Test Methods for Flexural Properties of Unreinforced
included except where particular delineation to biomaterials and Reinforced Plastics and Electrical Insulating Materi-
may be more clearly stated. als
1.2 This terminology is therefore intended to be selective of D 882 Test Methods for Tensile Properties of Thin Plastic
terms used generally in materials science and technology and Sheeting
published in a number of documents, such as those listed in the D 1003 Test Method for Haze and Luminous Transmittance
succeeding sections. The listing is also intended to define terms of Transparent Plastics
that appear prominently within other ASTM standards and do E 380 Practice for Use of the International System of Units
not appear elsewhere. (SI) (the Modernized Metric System)
1.3 The definitions are substantially identical to those pub-
3. Terminology
lished in other ASTM standards on metals, ceramics and glass,
rubbers and polymers, etc., or published by other standards 3.1 Definitions:
writing organizations, such as International Standards Organi-
acetal plastic, n—a plastic based on polymers having a
zation (ISO), American Institute of Mechanical Engineers
predominance of acetal linkages in the main chain. (See also
(AIME), American Society of Plastic and Reconstructive
polyoxymethylene.) D-20
Surgeons (ASPR), and Tissue Culture Association (TCA).
acrylic plastic, n—a plastic based on polymers made with
1.4 A need exists for this terminology to supplement current
acrylic acid or a structural derivative of acrylic acid. D-20
documents on terminology which concentrate on materials.
addition polymerization, n—polymerization in which mono-
This terminology covers each of the following disciplines:
mers are linked together without the splitting off of water or
plastics (polymers), rubber (elastomers), and textiles (polymer
other simple molecules and involves the opening of a double
derived).
bond. D-20
1.5 An increasing number of product (polymeric, metallur-
aging, n—the process of exposing materials to an environment
gical, and ceramic types) designations and designations for
for an interval of time. D-20
chemical, physical, mechanical, and analytical tests and stan-
aging effect, n—a change in a material brought about by
dards are coming into common usage in the literature and
exposure of the material to an environment for an interval of
commerce of biomaterials in medical and surgical devices and
time.
clinical services. Section 2 lists those documents referenced in
alkyd resin, n—a polyester convertible into a crosslinked
this terminology.
form; requiring a reactant of functionality higher than two,
1.6 Table 1 lists abbreviated, anagramic designations. An-
or having double bonds. D-20
nex A1 is a thesaurus of general usage terms relating to
apparent density—see density, apparent.
biomaterials.
artificial weathering, n—exposure of a material to laboratory
conditions that simulate outdoor weathering.
This terminology is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 08.01.
F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 14.02. Excerpts in Related Material
Current edition approved Nov. 24, 1989. Published January 1990. sections of all other volumes.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1251 – 89 (1995)
A,B
TABLE 1 Abbreviated, Anagramic Designations—Acronyms
Term Classification Descriptive Term in Full
AAS analytic, chemical atomic absorption spectroscopy
ABC plastic, polymer acryline bone cement
ABS plastic, polymer acrylonitrile-butadiene-styrene polymer
AN polymer, monomer acrylonitrile
ATR-IR analytic, chemical attenuated total reflectance—infrared
CA plastic, polymer cellulose acetate (sheet X ray)
CAB plastic, polymer cellulose acetate-butyrate
CP plastic, polymer cellulose propionate or cellulose acetate-propionate
DSC analytic, physical differential scanning calorimetry
DTA analytic, physical differential thermal analysis
EDTA analyses ethylene dinitrilo tetraacetic acid
EPM/EPDM elastomer ethylene-propylene terpolymer
EPR elastomer see EPM/EDPM above
ESCA analytic, chemical used for X-ray photoelectron spectroscopy
ETFE analytic, chemical (ethylene-tetrafluoroethylene-fluoroplastics)
FEP plastics, polymers perfluoro(ethylene-propylene) copolymer
GC analytic, chemical gas chromatography
HEMA plastic, polymer hydroxyethyl methacrylate (polymer)
HPLC analytic, chemical high performance liquid chromatography
IR analytic, physical infrared spectroscopy (for example, IR scan)
kPA mechanical, physical kiloPascal (unit of pressure—see Practice E 380, Appendix)
MPa mechanical, physical megaPascal (unit of pressure—see Practice E 380, Appendix)
MW (mw) physical, molecular molecular weight
MWD (mwd) physical, molecular molecular weight distribution (see mw, above)
MRI clinical magnetic resonance imaging (diagnostic application of nmr)
MRS analytic, chemical magnetic resonance spectroscopy (diagnostic application of nmr)
NBR elastomer, polymer nitrile-butadiene rubber
NMR (nmr) analytic, physical nuclear magnetic resonance
PB elastomer, polymer polybutylene
PC plastic, polymer polycarbonate
PCTFE plastic, polymer polychlorotrifluoroethylene
PDMS elastomer, polymer fluid silicone, polydimethyl siloxane
PE plastic, polymer polyethylene
PET plastic, polymer poly(ethylene terephthalate)
PFA plastic, polymer perfluoroalkoxy fluorocarbon polymer
PMMA plastic, polymer poly(methyl methacrylate)
PTFE plastic, polymer polytetrafluoroethylene
PU plastic or elastomer polymer polyurethane
PVA plastic, polymer poly(vinyl alcohol) (often poly(vinyl acetate))
PVAc plastic, polymer poly(vinyl acetate)
PVC plastic, polymer poly(vinyl chloride)
PVDC plastic, polymer poly(vinylidene chloride)
PVP polymer poly(vinyl pyttolidone)
RTV elastomer, plastic room temperature vulcanization
SAN elastomer, polymer styrene-acrylonitrile polymer
SB elastomer, polymer styrene-butadiene polymer
SEM analytic, microscopy scanning electron microscopy (cf TEM)
SR elastomer, polymer styrene rubber (elastomer)
TEM analytic, microscopy transmission electron microscopy (cf SEM)
TAR device or prosthesis total ankle replacement
TER device or prosthesis total elbow replacement
THR device or prosthesis total hip replacement
TJR device or prosthesis total joint replacement
TKR device or prosthesis total knee replacement
TSR device or prosthesis total shoulder replacement
TWR device or prosthesis total wrist replacement
UHMW plastic, polymer ultrahigh molecular weight polyethylene (stated polymer)
UMHWPE plastic, polymer ultrahigh molecular weight polyethylene (see UHMW)
UV analytic, physical ultraviolet light spectroscopy
VCM polymer, monomer vinyl chloride monomer content
XPS analytic, chemical X-ray photoelectric spectroscopy (also called ESCA)
XRD analytic, physical X-ray diffraction
A
If a method or name is used for the first time in a text (paper, etc.), it must be presented in full with the abbreviation in brackets.
B
If the text is long or consists of several chapters, the full name must be repeated in reasonable sequences, at least when first mentioned in a new chapter.
DISCUSSION—Exposure conditions may be cyclic, involving changes
tion of the surface, with boundaries that may be more or less
in temperature, relative humidity, radiant energy, and many other
sharply defined, somewhat resembling in shape a blister on
elements found in the atmosphere in various geographical areas. The
the human skin. D-20
laboratory exposure conditions are usually intensified beyond those
block copolymer, n—an essentially linear copolymer in which
encountered in actual out-door exposure to accelerate the effect.
there are repeated sequences of polymeric segments of
D-20
different chemical structure. D-20
blister, n—in sheet plastics, an imperfection, a rounded eleva-
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1251 – 89 (1995)
bloom, n—a visible exudation or efflorescence of a perfor- cure, v—to change the properties of a polymeric system into a
mance additive on the surface of a material. D-20 more stable, usable condition by the use of heat, radiation, or
bulk density—the weight per unit volume of a material reaction with chemical additives.
including voids inherent in the material as tested.
DISCUSSION—Cure may be accomplished, for example, by removal of
solvent or crosslinking. ISO
DISCUSSION—This term is sometimes used synonymously with ap-
parent density.
degradation, n—a deleterious change in the chemical struc-
bulk factor, n—the ratio of the volume of a given mass of
ture, physical properties, or appearance of a plastic.
molding material to its volume in the molded form.
density, apparent, n—the weight in air of a unit of volume of
a material.
DISCUSSION—The bulk factor is also equal to the ratio of the density
of the material to its apparent density in the unmolded form. D-20
DISCUSSION—This term is sometimes used synonymously with bulk
ISO
density.
butylene plastic—plastic based on resins made by the poly- density, bulk, n—the weight in air of a unit of volume of a
merization of butene or copolymerization of butene with one material.
or more unsaturated compounds, the butene being in greatest
DISCUSSION—This term is commonly used synonymously with ap-
amount by weight. D-20
parent density (1973). D-20
cast film, n—a film made by depositing a layer of plastic,
elastomer, n—a macromolecular material that at room tem-
either molten, in solution, or in a dispersion, onto a surface,
perature returns rapidly to approximately its initial dimen-
solidifying the deposit and removing the film from the
sions and shape after substantial deformation by a weak
surface. D-20
stress and release of the stress. D-20
cell, n—a small partially or completely enclosed cavity.
epoxy plastic, n—a thermoplastic or thermosetting plastic
D-20
containing ether or hydroxyalkyl repeating units, or both,
cell, closed—see closed cell.
resulting from the ring-opening reactions of lower-molecular
cell, open—see open cell.
weight polyfunctional oxirane resins, or compounds, with
chemically foamed polymeric material, n—a cellular mate-
catalysts or with various polyfunctional acidic or basic
rial in which the cells are formed by gases generated by
coreactants.
thermal decomposition or other chemical reaction. D-20
chlorofluorocarbon plastic, n—a plastic based on polymers
DISCUSSION—Epoxy plastics often are modified by the incorporation
made with monomers composed of chlorine, fluorine, and
of diluents, plasticizers, fillers, thixotropic agents, or other materials.
carbon only. ISO
D-20
chlorofluorohydrocarbon plastic, n—a plastic based on poly-
ethylene plastic—a plastic based on polymers of ethylene or
mers made with monomers composed of chlorine, fluorine,
copolymers of ethylene with other monomers, the ethylene
hydrogen, and carbon only. ISO
being in greatest amount by mass. ISO
closed cell, n—a cell totally enclosed by its walls and hence
filler, n—a relatively inert material added to a plastic to modify
not interconnecting with other cells. (See also cell and open
its strength, performance, working properties, or other quali-
cell.) ISO
ties, or to lower costs. (See also reinforced plastic.)
closed-cell foamed plastic, n—a plastic in which almost all
film, n—in plastics, term for sheeting having a nominal
the cells are noninterconnecting. D-20
thickness not greater than 0.25 mm (0.01 in.). (See also
cold flow—see preferred term creep.
sheeting.)
compression molding, n—a process for molding a material in
fluorocarbon plastic, n—a plastic based on polymers made
a confined cavity by applying pressure and usually heat.
with monomers composed of fluorine and carbon only.
D-20
condensation polymer, n—polymerization in which during an
DISCUSSION—When the monomer is essentially tetrafluoro-ethylene,
acid/base reaction a small molecule is often split out. the prefix TFE may be used to designate these materials. When the
resins are copolymers of tetrafluoro-ethylene and hexafluoropropylene,
copolymer, n—a polymer consisting of molecules character-
the resins may be designated with the prefix FEP. Other prefixes may be
ized by the repetition (neglecting ends, branch junctions and
adopted to designate other fluorocarbon plastics. ISO
other irregularities) of two or more different types of
monomeric units. See polymer. D-20
fluorohydrocarbon plastic, n—a plastic based on polymers
copolymerization—see polymerization and copolymer.
made with monomers composed of fluorine, hydrogen, and
crazing, n—apparent fine cracks at or under the surface of a
carbon only. ISO
plastic.
fluoroplastic, n—a plastic based on polymers with monomers
containing one or more atoms of fluorine or copolymers of
DISCUSSION—The crazed areas are composed of polymeric material
such monomers with other monomers, the fluorine-
of lower density than the surrounding matrix.
containing monomer(s) being in greatest amount by mass.
creep, n—the time-dependent part of strain resulting from
stress.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
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F 1251 – 89 (1995)
(See also fluorocarbon plastic, chlorofluorocarbon plas- phenolic plast
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