ASTM F702-98a

Standard Specification for Polysulfone Resin for Medical Applications

SCOPE
1.1 This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications (as defined in Terminology D883). This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices or components of medical devices.
1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for a specific application. Therefore, properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy.
1.3 The use of this resin in medical devices should be restricted to nonimplant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed.
1.4 The biocompatibility of plastic compounds made up of polysulfone resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polysulfone should not be assumed on the basis of resin compatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. Note that the types, levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications.
1.5 All values in this standard are in SI units with the equivalent values in inch-pound units given in parentheses where applicable.
1.6 This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Oct-1998
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaced By: ASTM F702-98ae1 - Standard Specification for Polysulfone Resin for Medical Applications
• Effective Date: 10-Oct-1998

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NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn.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: F 702 – 98a
AMERICAN SOCIETY FOR TESTING AND MATERIALS
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Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
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Polysulfone Resin for Medical Applications
This standard is issued under the fixed designation F 702; 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 Dielectric Strength of Solid Electrical Insulating Materials
2
at Commercial Power Frequencies
1.1 This specification covers polysulfone resin (poly(oxy-p-
D 256 Test Methods for Impact Resistance of Plastics and
phenylenesulfonyl-p-phenyleneoxy-p-
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Electrical Insulating Materials
phenyleneisopropylidene-p-phenylene)) for medical applica-
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D 570 Test Method for Water Absorption of Plastics
tions. This specification provides requirements and associated
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D 638 Test Method for Tensile Properties of Plastics
test methods for a form of this thermoplastic which is intended
D 648 Test Method for Deflection Temperature of Plastics
for use in manufacturing medical devices or components of
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Under Flexural Load
medical devices.
D 696 Test Method for Coefficient of Linear Thermal Ex-
1.2 As with any material, some characteristics may be
3
pansion of Plastics Between − 30°C and 30°C
altered by the processing techniques (such as molding, extru-
3
D 883 Terminology Relating to Plastics
sion, machining, sterilization, etc.) required for a specific
D 955 Test Method of Measuring Shrinkage from Mold
application. Therefore, properties of fabricated forms of this
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Dimensions of Molded Plastics
resin should be evaluated using appropriate test methods to
D 1238 Test Method for Flow Rates of Thermoplastics by
assure safety and efficacy.
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Extrusion Plastometer
1.3 The use of this resin in medical devices should be
D 1505 Test Method for Density of Plastics by the Density-
restricted to nonimplant applications until biocompatibility
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Gradient Technique
evaluations appropriate for the intended applications are suc-
3
D 1898 Practice for Sampling of Plastics
cessfully completed.
D 2576 Test Method for Metals in Water and Waste Water
1.4 The biocompatibility of plastic compounds made up of
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by Atomic Absorption Spectrophotometry
polysulfone resin containing colorants, fillers, processing aids
D 3750 Practice for Determination of Number-Average Mo-
or other additives as well as polymer blends which contain
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lecular Weight of Polymers by Membrane Osmometry
polysulfone should not be assumed on the basis of resin
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F 619 Practice for Extraction of Medical Plastics
compatibility alone. Their biocompatibility must be established
F 748 Practice for Selecting Generic Biological Test Meth-
by testing the final (end-use) compositions using evaluation
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ods for Materials and Devices
methods appropriate for the intended applications. It should be
2.2 Code of Federal Regulations:
noted that the types, levels and biological effects of extractives
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Title 21 CFR Subpart 177.2500
yielded by the additives contained in a compound or blend may
also have to be evaluated for some end-use applications.
3. Chemical Requirements
1.5 All values in this standard are in SI units with the
3.1 The polysulfone resin consists solely of the alternating
equivalent values in inch-pound units given in parentheses
copolymer which may be produced when the disodium salt of
where applicable.
4,48-isopropylidenediphenol is made to react stoichiometri-
1.6 This standard does not purport to address all of the
cally with 4,48-dichlorodiphenyl sulfone such that the finished
concerns, if any, associated with its use. It is the responsibility
resins have a minimum number average molecular weight of
of the user of this standard to establish appropriate safety and
24 000. The molecular weight shall be determined by osmotic
health practices and determine the applicability of regulatory
pressure in monochlorobenzene using the method described in
limitations prior to use.
Practice D 3750 or an equivalent method. The weight average
2. Referenced Documents molecular weight shall be equal to or greater than two times the
number average molecular weight.
2.1 ASTM Standards:
D 149 Test Method for Dielectric Breakdown Voltage and
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Annual Book of ASTM Standards, Vol 10.01.
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Annual Book of ASTM Standards, Vol 08.01.
1
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This specification is under the jurisdiction of ASTM Committee F-4 on Medical Discontinued—See 1980 Annual Book of ASTM Standards, Part 31.
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and Surgical Materials and Devices and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 08.03.
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F04.11 on Polymeric Materials. A
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