ASTM F702-98a(2003)
(Specification)Standard Specification for Polysulfone Resin for Medical Applications
Standard Specification for Polysulfone Resin for Medical Applications
ABSTRACT
This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications. Requirements and associated test methods for a form of this thermoplastic intended for use in manufacturing medical devices or components of medical devices are provided. 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. The molecular weight of the resin shall be determined by osmotic pressure in monochlorobenzene. The polysulfone resin shall yield an infrared transmittance spectrum that exhibits major transmittance bands only at the same wavelengths as that of a reference spectrum. Medical devices made of polysulfone may be repeatedly sterilized through steam, ethylene oxide, irradiation, and dry heat sterilization, among others. The polysulfone resin shall be tested for nonvolatile content and melt flow, and shall conform to the specified electrical, physical and mechanical, and thermal properties.
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 D 883). 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.
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Designation: F702 – 98a (Reapproved 2003)
Standard Specification for
Polysulfone Resin for Medical Applications
ThisstandardisissuedunderthefixeddesignationF702;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This specification covers polysulfone resin (poly(oxy-p- 2.1 ASTM Standards:
phenylenesulfonyl-p-phenyleneoxy-p- D149 Test Method for Dielectric Breakdown Voltage and
phenyleneisopropylidene-p-phenylene)) for medical applica- Dielectric Strength of Solid Electrical Insulating Materials
tions (as defined in Terminology D883). This specification at Commercial Power Frequencies
provides requirements and associated test methods for a form D256 Test Methods for Determining the Izod Pendulum
of this thermoplastic which is intended for use in manufactur- Impact Resistance of Plastics
ing medical devices or components of medical devices. D570 Test Method for Water Absorption of Plastics
1.2 As with any material, some characteristics may be D638 Test Method for Tensile Properties of Plastics
altered by the processing techniques (such as molding, extru- D648 Test Method for Deflection Temperature of Plastics
sion, machining, sterilization, and so forth) required for a Under Flexural Load in the Edgewise Position
specific application. Therefore, properties of fabricated forms D696 Test Method for Coefficient of Linear Thermal Ex-
ofthisresinshouldbeevaluatedusingappropriatetestmethods pansion of Plastics Between Ø30°C and 30°C with a
to assure safety and efficacy. Vitreous Silica Dilatometer
1.3 The use of this resin in medical devices should be D883 Terminology Relating to Plastics
restricted to nonimplant applications until biocompatibility D955 Test Method of Measuring Shrinkage from Mold
evaluations appropriate for the intended applications are suc- Dimensions of Thermoplastics
cessfully completed. D1238 Test Method for Melt Flow Rates of Thermoplastics
1.4 The biocompatibility of plastic compounds made up of by Extrusion Plastometer
polysulfone resin containing colorants, fillers, processing aids, D1505 Test Method for Density of Plastics by the Density-
or other additives as well as polymer blends which contain Gradient Technique
polysulfone should not be assumed on the basis of resin D1898 Practice for Sampling of Plastics
compatibilityalone.Theirbiocompatibilitymustbeestablished D3750 Practice for Determination of Number-Average Mo-
by testing the final (end-use) compositions using evaluation lecular Weight of Polymers by Membrane Osmometry
methods appropriate for the intended applications. Note that F619 Practice for Extraction of Medical Plastics
the types, levels, and biological effects of extractives yielded F748 Practice for Selecting Generic Biological Test Meth-
by the additives contained in a compound or blend may also ods for Materials and Devices
have to be evaluated for some end-use applications. 2.2 Code of Federal Regulations:
1.5 All values in this standard are in SI units with the Title 21 CFR Subpart 177.1655
equivalent values in inch-pound units given in parentheses
3. Chemical Requirements
where applicable.
3.1 The polysulfone resin consists solely of the alternating
1.6 This standard does not purport to address all of the
concerns, if any, associated with its use. It is the responsibility copolymer which may be produced when the disodium salt of
4,48-isopropylidenediphenol is made to react stoichiometri-
of the user of this standard to establish appropriate safety and
health practices and determine the applicability of regulatory cally with 4,48-dichlorodiphenyl sulfone such that the finished
resins have a minimum number average molecular weight of
limitations prior to use.
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Apr. 10, 2003. Published May 2003. Originally the ASTM website.
´1 3
approved in 1981. Last previous edition approved in 1998 as F702 – 98a . DOI: AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
10.1520/F0702-98AR03. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F702 – 98a (2003)
FIG. 1 Polysulfone Infrared Spectrum—Percent Transmittance for 0.0005 in. Film
24 000. The molecular weight shall be determined by osmotic plaques shall be examined visually under fluorescent light
pressure in monochlorobenzene using the method described in usinga2to33 magnifier to determine the number and size of
Practice D3750 or an equivalent method. The weight average any contaminant specks present, rating them in accordance
molecularweightshallbeequaltoorgreaterthantwotimesthe withTable2.Thetotallevelofcontaminationisthencalculated
number average molecular weight. by multiplying the number of specks in each size range by the
3.2 Polysulfone resins shall conform to the requirements of appropriate numerical rating and summing. A total rating
21 CFR 177.1655. In addition to the total extractables evalu- greater than 12 shall be cause for rejection of the material.
ation described in the CFR, maximum levels and types of
6.2 As determined by agreement between the purchaser and
extractable metals shall be established in accordance with the the supplier, polysulfone resin may be inspected for pyrogenic
requirements of the intended use of the resin (1, 2).
contamination using either of the following tests:
3.3 The polysulfone resin shall yield an infrared transmit-
6.2.1 USP Pyrogen Test (3).
tance spectrum which exhibits major transmittance bands only
6.2.2 Limulus Amebocyte Lysate (LAL) Test for Pyrogens
at the same wavelengths as appear on the attached reference
(3).
spectrum (see Fig. 1).
6.3 The material shall be properly identified including lot or
batch numbers, date of manufacture, and recommended
4. Physical Requirements
method of storage.
4.1 Polysulfone resin may be processed by most techniques
6.4 The material, before processing, as well as the end-use
available for thermop
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