ASTM F1251-89(2003)

Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

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, and so forth, 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 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.
WITHDRAWN RATIONALE
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.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this terminology was withdrawn in January 2012 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

• Status: Withdrawn
• Publication Date: 09-Apr-2003
• Withdrawal Date: 05-Jan-2012
• ICS: 01.040.11 - Health care technology (Vocabularies)
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F1251-89(1995) - Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
• Effective Date: 10-Apr-2003
• Referred By: ASTM F665-09(2015) - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2051-00(2022) - Standard Specification for Implantable Saline-Filled Breast Prostheses
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Apr-2003
• Referred By: ASTM F3209-16 - Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy
• Effective Date: 10-Apr-2003
• Referred By: ASTM F1441-03(2022) - Standard Specification for Soft-Tissue Expander Devices
• Effective Date: 10-Apr-2003
• Referred By: ASTM D5747/D5747M-21 - Standard Practice for Tests to Evaluate the Chemical Resistance of Geomembranes to Liquids
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2103-18 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 10-Apr-2003
• Referred By: ASTM F703-18(2022) - Standard Specification for Implantable Breast Prostheses
• Effective Date: 10-Apr-2003
• Referred By: ASTM F881-94(2022) - Standard Specification for Silicone Elastomer Facial Implants
• Effective Date: 10-Apr-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1251–89 (Reapproved 2003)
Standard Terminology Relating to
Polymeric Biomaterials in Medical and Surgical Devices
This standard is issued under the fixed designation F1251; 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 (´) 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 D638 Test Method for Tensile Properties of Plastics
used relative to medical and surgical materials and devices. D747 Test Method for Apparent Bending Modulus of Plas-
Terms that are generally understood and in common usage or tics by Means of a Cantilever Beam
adequately defined in other readily available references are not D790 Test Methods for Flexural Properties of Unreinforced
included except where particular delineation to biomaterials and Reinforced Plastics and Electrical Insulating Materials
may be more clearly stated. D882 Test Method for Tensile Properties of Thin Plastic
1.2 This terminology is therefore intended to be selective of Sheeting
terms used generally in materials science and technology and D1003 Test Method for Haze and Luminous Transmittance
published in a number of documents, such as those listed in the of Transparent Plastics
succeedingsections.Thelistingisalsointendedtodefineterms SI 10–02 American National Standard for Use of the
that appear prominently within other ASTM standards and do International System of Units (SI): The Modern Metric
not appear elsewhere. System
1.3 The definitions are substantially identical to those pub-
3. Terminology
lished in otherASTM standards on metals, ceramics and glass,
3.1 Definitions:
rubbers and polymers, and so forth, or published by other
standards writing organizations, such as International Stan-
acetal plastic, n—a plastic based on polymers having a
dards Organization (ISO), American Institute of Mechanical
predominance of acetal linkages in the main chain. (See also
Engineers (AIME), American Society of Plastic and Recon-
polyoxymethylene.) D20
structive Surgeons (ASPR), and Tissue Culture Association
acrylic plastic, n—a plastic based on polymers made with
(TCA).
acrylic acid or a structural derivative of acrylic acid. D20
1.4 Aneed exists for this terminology to supplement current
addition polymerization, n—polymerization in which mono-
documents on terminology which concentrate on materials.
mers are linked together without the splitting off of water or
This terminology covers each of the following disciplines:
other simple molecules and involves the opening of a double
plastics (polymers), rubber (elastomers), and textiles (polymer
bond. D20
derived).
aging, n—the process of exposing materials to an environment
1.5 An increasing number of product (polymeric, metallur-
for an interval of time. D20
gical, and ceramic types) designations and designations for
aging effect, n—a change in a material brought about by
chemical, physical, mechanical, and analytical tests and stan-
exposure of the material to an environment for an interval of
dards are coming into common usage in the literature and
time.
commerce of biomaterials in medical and surgical devices and
alkyd resin, n—a polyester convertible into a crosslinked
clinical services. Section 2 lists those documents referenced in
form; requiring a reactant of functionality higher than two,
this terminology.
or having double bonds. D20
1.6 Table 1 lists abbreviated, anagramic designations. An-
apparent density—see density, apparent.
nex A1 is a thesaurus of general usage terms relating to
artificial weathering, n—exposure of a material to laboratory
biomaterials.
conditions that simulate outdoor weathering.
DISCUSSION—Exposure conditions may be cyclic, involving changes
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Apr. 10, 2003. Published May 2003. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1989. Last previous edition approved in 1995 as F1251 – 89 (1995). Standards volume information, refer to the standard’s Document Summary page on
DOI: 10.1520/F1251-89R03. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1251–89 (2003)
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 SI 10–02, Appendix)
MPa mechanical, physical megaPascal (unit of pressure—see Practice SI 10–02, 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.
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. D20
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
D20
different chemical structure. D20
blister, n—in sheet plastics, an imperfection, a rounded eleva- bloom, n—a visible exudation or efflorescence of a perfor-
tion of the surface, with boundaries that may be more or less mance additive on the surface of a material. D20
F1251–89 (2003)
DISCUSSION—Cure may be accomplished, for example, by removal of
bulk density—the weight per unit volume of a material
solvent or crosslinking. ISO
including voids inherent in the material as tested.
DISCUSSION—This term is sometimes used synonymously with ap- degradation, n—a deleterious change in the chemical struc-
parent density.
ture, physical properties, or appearance of a plastic.
density, apparent, n—the weight in air of a unit of volume of
bulk factor, n—the ratio of the volume of a given mass of
a material.
molding material to its volume in the molded form.
DISCUSSION—This term is sometimes used synonymously with bulk
DISCUSSION—The bulk factor is also equal to the ratio of the density
density.
of the material to its apparent density in the unmolded form. D20
ISO density, bulk, n—the weight in air of a unit of volume of a
material.
butylene plastic—plastic based on resins made by the poly-
DISCUSSION—This term is commonly used synonymously with ap-
merization of butene or copolymerization of butene with one
parent density (1973). D20
ormoreunsaturatedcompounds,thebutenebeingingreatest
amount by weight. D20
elastomer, n—a macromolecular material that at room tem-
cast film, n—a film made by depositing a layer of plastic,
perature returns rapidly to approximately its initial dimen-
either molten, in solution, or in a dispersion, onto a surface,
sions and shape after substantial deformation by a weak
solidifying the deposit and removing the film from the
stress and release of the stress. D20
surface. D20
epoxy plastic, n—a thermoplastic or thermosetting plastic
cell, n—a small partially or completely enclosed cavity. D20
containing ether or hydroxyalkyl repeating units, or both,
cell, closed—see closed cell.
resultingfromthering-openingreactionsoflower-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. D20
DISCUSSION—Epoxy plastics often are modified by the incorporation
chlorofluorocarbon plastic, n—a plastic based on polymers
of diluents, plasticizers, fillers, thixotropic agents, or other materials.
made with monomers composed of chlorine, fluorine, and
D20
carbon only. ISO
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—arelativelyinertmaterialaddedtoaplastictomodify
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. D20
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.
D20
DISCUSSION—When the monomer is essentially tetrafluoro-ethylene,
condensation polymer, n—polymerization in which during an
the prefix TFE may be used to designate these materials. When the
acid/base reaction a small molecule is often split out.
resins are copolymers of tetrafluoro-ethylene and hexafluoropropylene,
copolymer, n—a polymer consisting of molecules character-
theresinsmaybedesignatedwiththeprefixFEP.Otherprefixesmaybe
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
fluorohydrocarbon plastic, n—a plastic based on polymers
monomeric units. See polymer. D20
made with monomers composed of fluorine, hydrogen, and
copolymerization—see polymerization and copolymer.
carbon only. ISO
crazing, n—apparent fine cracks at or under the surface of a
fluoroplastic, n—a plastic based on polymers with monomers
plastic.
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.
(See also fluorocarbon plastic, chlorofluorocarbon plas-
creep, n—the time-dependent part of strain resulting from
tic, fluorohydrocarbon plastic,and chlorofluorohydrocar-
stress.
bon plastic.)
cure, v—to change the properties of a polymeric system into a
gel, n—in polymer, a semisolid system consisting of a network
morestable,usableconditionbytheuseofheat,radiation,or
of solid aggregates in which liquid is held.
reaction with chemical additives.
F1251–89 (2003)
DISCUSSION—Gels have very low strengths and do not flow like a
pit, n—in plastics, an imperfection, a small crater in the
liquid. They are soft, flexible, and may rupture under their own weight
surface, the depth and width of
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