ASTM F702-18
(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-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it 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 the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies.
1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies.
1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Buy Standard
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation:F702 −18
Standard Specification for
1
Polysulfone Resin for Medical Applications
ThisstandardisissuedunderthefixeddesignationF702;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 This specification covers polysulfone resin (poly(oxy-1,
1.7 This international standard was developed in accor-
4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,
dance with internationally recognized principles on standard-
4–phenylene)) as defined in ISO 25137–1, supplied by a
ization established in the Decision on Principles for the
vendorinvirginform(pellets,powder,fabricatedformsandso
Development of International Standards, Guides and Recom-
forth) for medical applications. This specification provides
mendations issued by the World Trade Organization Technical
requirementsandassociatedtestmethodsforthisthermoplastic
Barriers to Trade (TBT) Committee.
whenitisintendedforuseinmanufacturingmedicaldevicesor
components of medical devices.
2. Referenced Documents
1.2 As with any material, some characteristics may be 2
2.1 ASTM Standards:
altered by the processing techniques (such as molding,
D256Test Methods for Determining the Izod Pendulum
extrusion, machining, sterilization, and so forth) required for
Impact Resistance of Plastics
the production of a specific part or device. Therefore, proper-
D638Test Method for Tensile Properties of Plastics
ties of fabricated forms of this resin should be evaluated using
D648Test Method for Deflection Temperature of Plastics
test methods which are appropriate to ensure safety and
Under Flexural Load in the Edgewise Position
efficacy as agreed upon by the vendor, purchaser, and regulat-
D792Test Methods for Density and Specific Gravity (Rela-
ing bodies.
tive Density) of Plastics by Displacement
1.3 Thestandardallowsfordesignationofpolysulfoneresin D6394Classification System for and Basis for Specification
for all medical applications. The actual extent of performance for Sulfone Plastics (SP)
and suitability for a specific application must be evaluated by D7474Practice for Determining Residual Stresses in Ex-
the vendor, purchaser, and regulating bodies. trudedorMoldedSulfonePlastic(SP)PartsbyImmersion
in Various Chemical Reagents
1.4 The properties included in this specification are those
F748PracticeforSelectingGenericBiologicalTestMethods
applicable for unfilled polysulfone (PSU) polymers with the
for Materials and Devices
addition of colorants and processing aids. Indicated properties
3
2.2 ISO Standards:
are for injection molded forms. Forms containing fillers or
ISO 10993–1Biological Evaluation of Medical Devices—
other additives, as well as polymer blends which contain PSU,
Part1:EvaluationandTestingWithinaRiskManagement
or reclaimed materials, are not covered by this specification.
Process
1.5 The values stated in SI units are to be regarded as
ISO 17025General Requirements for the Competence of
standard. No other units of measurement are included in this
Testing and Calibration Laboratories
standard.
ISO 25137–1Plastics—Sulfone Polymer Moulding and Ex-
1.6 When evaluating material in accordance with this trusion Materials—Part I: Designation System and Basis
specification, hazardous materials, operations, and equipment for Specifications
maybeinvolved.Thisstandarddoesnotpurporttoaddressall
3. Significance and Use
of the concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3.1 This specification is designed to recommend test meth-
odstoestablishareasonablelevelofconfidenceconcerningthe
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 Dec. 1, 2018. Published February 2019. Originally the ASTM website.
3
approved in 1981. Last previous edition approved in 2010 as F702–10. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0702-18. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Dr
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F702 − 10 F702 − 18
Standard Specification for
1
Polysulfone Resin for Medical Applications
This standard is issued under the fixed designation F702; 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
1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,
4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for
medical applications. This specification provides requirements and associated test methods for this thermoplastic when it 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 the production of a specific part or device. Therefore, properties of fabricated
forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by
the vendor, purchaser, and regulating bodies.
1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and
suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies.
1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition
of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives,
as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be
involved. 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D638 Test Method for Tensile Properties of Plastics
D648 Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D6394 Specification for Sulfone Plastics (SP)
D7474 Practice for Determining Residual Stresses in Extruded or Molded Sulfone Plastic (SP) Parts by Immersion in Various
Chemical Reagents
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3
2.2 ISO Standards:
ISO 1099310993–1 Biological Evaluation of Medical DevicesDevices—Part 1: Evaluation and Testing Within a Risk
Management Process
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Sept. 1, 2010Dec. 1, 2018. Published October 2010February 2019. Originally approved in 1981. Last previous edition approved in 20032010
as F702 – 98a (2003).F702 – 10. DOI: 10.1520/F0702-10.10.1520/F0702-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.