ASTM F997-18
(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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 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.
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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: F997 −18
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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This specification covers polycarbonate resin and pro-
vides requirements and associated test methods for this ther-
2. Referenced Documents
moplastic when it is to be used in the manufacture of medical
2
devices or components of medical devices.
2.1 ASTM Standards:
D256 Test Methods for Determining the Izod Pendulum
1.2 As with any material, some characteristics may be
Impact Resistance of Plastics
altered by the processing techniques (such as molding,
D570 Test Method for Water Absorption of Plastics
extrusion, machining, assembly, sterilization, and so forth)
D638 Test Method for Tensile Properties of Plastics
required for the production of a specific part or device.
Therefore,propertiesoffabricatedformsofthisresinshouldbe D648 Test Method for Deflection Temperature of Plastics
Under Flexural Load in the Edgewise Position
evaluated using those test methods that are appropriate to
assure safety and efficacy. D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materi-
1.3 The properties included in this specification are those
als
applicable for polycarbonate only. The biocompatibility of
D792 Test Methods for Density and Specific Gravity (Rela-
plastic compounds made up of polycarbonate resin containing
tive Density) of Plastics by Displacement
colorants, fillers, processing aids, or other additives, as well as
D883 Terminology Relating to Plastics
polymer blends which contain polycarbonate, should not be
D955 Test Method of Measuring Shrinkage from Mold
assumed. The biocompatibility of these modified polycarbon-
Dimensions of Thermoplastics
ates must be established by testing the final (end-use) compo-
D1003 Test Method for Haze and Luminous Transmittance
sitions using the appropriate methods of evaluation. In
of Transparent Plastics
addition,thebiocompatibilityofthematerialdependstoalarge
D1238 Test Method for Melt Flow Rates of Thermoplastics
degree on the nature of the end-use application. It is, therefore,
by Extrusion Plastometer
necessary to specify a set of biocompatibility test methods for
D1600 Terminology forAbbreviatedTerms Relating to Plas-
each new and distinct application.
tics
1.4 This standard does not purport to address all of the
D3892 Practice for Packaging/Packing of Plastics
safety concerns, if any, associated with its use. It is the
D3935 Classification System and Basis for Specification for
responsibility of the user of this standard to establish appro-
Polycarbonate (PC) Unfilled and Reinforced Material
priate safety, health, and environmental practices and deter-
F748 PracticeforSelectingGenericBiologicalTestMethods
mine the applicability of regulatory limitations prior to use.
for Materials and Devices
1.5 This international standard was developed in accor-
2.2 Underwriter’s Laboratories Document:
dance with internationally recognized principles on standard-
UL Standard 94 Tests for Flammability of Plastic Materials
ization established in the Decision on Principles for the
3
for Parts in Devices and Appliances
Development of International Standards, Guides and Recom-
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 1986. Last previous edition approved in 2010 as F997 – 10. DOI: Available from Underwriters Laboratories (UL), 333 Pfingsten Rd.,
10.1520/F0997-18. 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
1
---------------------- Page: 1 ----------------------
F997 − 18
2.3 Code of Federal Regulations: 6. Physical Properties
4
Title 21 CFR Subpart 177.1580 Polycarbonate Resins
6.1 The physical properties
...
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 − 10 F997 − 18
Standard Specification for
1
Polycarbonate Resin for Medical Applications
This standard is issued under the fixed designation F997; 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 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.5 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
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 (Withdrawn 1998)
D3892 Practice for Packaging/Packing of Plastics
D3935 Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
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 Jan. 1, 2010Dec. 1, 2018. Published January 2010February 2019. Originally approved in 1986. Last previous edition approved in 20032010 as
F997 – 98aF997 – 10.(2003). DOI: 10.1520/F0997-10. 10.1520/F0997-18.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F997 − 18
2.2 Underwriter’s Laboratories Document:
3
UL Standard 94 Tests andfor Flammability of Plastic
...
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