ASTM F997-10
(Specification)Standard Specification for Polycarbonate Resin for Medical Applications
Standard Specification for Polycarbonate Resin for Medical Applications
ABSTRACT
This specification covers the general, physical property, and biocompatibility requirements, and the associated test methods for establishing a reasonable level of confidence concerning the performance of unfilled thermoplastic polycarbonate resin for use in the manufacture of medical devices or the components thereof.
SCOPE
1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of 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, assembly, 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 those test methods that are appropriate to assure safety and efficacy.
1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.
1.4 This standard does not purport to address all of the safety 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:F997 −10
Standard Specification for
1
Polycarbonate Resin for Medical Applications
ThisstandardisissuedunderthefixeddesignationF997;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 Impact Resistance of Plastics
D570 Test Method for Water Absorption of Plastics
1.1 This specification covers polycarbonate resin and pro-
D638 Test Method for Tensile Properties of Plastics
vides requirements and associated test methods for this ther-
D648 Test Method for Deflection Temperature of Plastics
moplastic when it is to be used in the manufacture of medical
Under Flexural Load in the Edgewise Position
devices or components of medical devices.
D790 Test Methods for Flexural Properties of Unreinforced
1.2 As with any material, some characteristics may be
and Reinforced Plastics and Electrical Insulating Materi-
altered by the processing techniques (such as molding,
als
extrusion, machining, assembly, sterilization, and so forth)
D792 Test Methods for Density and Specific Gravity (Rela-
required for the production of a specific part or device.
tive Density) of Plastics by Displacement
Therefore,propertiesoffabricatedformsofthisresinshouldbe
D883 Terminology Relating to Plastics
evaluated using those test methods that are appropriate to
D955 Test Method of Measuring Shrinkage from Mold
assure safety and efficacy.
Dimensions of Thermoplastics
D1003 Test Method for Haze and Luminous Transmittance
1.3 The properties included in this specification are those
applicable for polycarbonate only. The biocompatibility of of Transparent Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics
plastic compounds made up of polycarbonate resin containing
colorants, fillers, processing aids, or other additives, as well as by Extrusion Plastometer
D1600 Terminology forAbbreviatedTerms Relating to Plas-
polymer blends which contain polycarbonate, should not be
assumed. The biocompatibility of these modified polycarbon- tics
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
ates must be established by testing the final (end-use) compo-
sitions using the appropriate methods of evaluation. In D3892 Practice for Packaging/Packing of Plastics
D3935 Specification for Polycarbonate (PC) Unfilled and
addition,thebiocompatibilityofthematerialdependstoalarge
Reinforced Material
degree on the nature of the end-use application. It is, therefore,
necessary to specify a set of biocompatibility test methods for F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
each new and distinct application.
2.2 Underwriter’s Laboratories Document:
1.4 This standard does not purport to address all of the
UL Standard 94 Tests and Flammability of Plastic Materials
safety concerns, if any, associated with its use. It is the
4
for Parts in Devices and Appliances
responsibility of the user of this standard to establish appro-
2.3 Code of Federal Regulations:
priate safety and health practices and determine the applica-
5
Title 21 CFR Subpart 177.1580
bility of regulatory limitations prior to use.
2.4 ISO Standard:
6
2. Referenced Documents
ISO 10993 Biological Evaluation of Medical Devices
2
2.1 ASTM Standards:
3. Significance and Use
D256 Test Methods for Determining the Izod Pendulum
3.1 This specification is designed to recommend physical,
chemical, and biological test methods to establish a reasonable
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
3
Subcommittee F04.11 on Polymeric Materials. The last approved version of this historical standard is referenced on
Current edition approved Jan. 1, 2010. Published January 2010. Originally www.astm.org.
4
approved in 1986. Last previous edition approved in 2003 as F997 – 98a(2003). Available from Underwriters Laboratories (UL), 333 Pfingsten Rd.,
DOI: 10.1520/F0997-10. Northbrook, IL 60062-2096, http://www.ul.com.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Robbins Ave., Philadelphia, PA 19111–5094, Attn: NPODS.
6
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 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
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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:F997–98a (Reapproved 2003) Designation: F997 – 10
Standard Specification for
1
Polycarbonate Resin for Medical Applications
ThisstandardisissuedunderthefixeddesignationF997;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
1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic
when it is to be used in the manufacture of 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, assembly, 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 those test methods that are appropriate to assure safety and efficacy.
1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic
compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer
blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be
established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the
biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to
specify a set of biocompatibility test methods for each new and distinct application.
1.4 This standard does not purport to address all of the safety 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D256 Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
D570 Test Method for Water Absorption 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
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D883 Terminology Relating to Plastics
D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D1003 Test Method for Haze and Luminous Transmittance of Transparent Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1600 Terminology for Abbreviated Terms Relating to Plastics
3
D1898 Practice for Sampling of Plastics
D3892 Practice for Packaging/Packing of Plastics
D3935 Specification for Polycarbonate (PC) Unfilled and Reinforced Material
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
2.2 Underwriter’s Laboratories Document:
4
UL Standard 94 Tests and Flammability of Plastic Materials for Parts in Devices and Appliances
2.3 Code of Federal Regulations:
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.
´1
Current edition approved Apr. 10, 2003. Published May 2003. Originally approved in 1986. Last previous edition approved in 1998 as F997–98a . DOI:
10.1520/F0997-98AR03.
Current edition approved Jan. 1, 2010. Published January 2010. Originally approved in 1986. Last previous edition approved in 2003 as F997 – 98a(2003). DOI:
10.1520/F0997-10.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book ofASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
4
Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111–5094, Attn: NPODS.
4
Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., Northbrook, IL 60062-2096, http://www.ul.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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