ASTM F997-98a

Standard Specification for Polycarbonate Resin for Medical Applications

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.

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 F997-98ae1 - Standard Specification for Polycarbonate 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NOTICE: This standard has either been superseded and replaced by a new version or
withdrawn.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 997 – 98a
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
1
Polycarbonate Resin for Medical Applications
This standard is issued under the fixed designation F 997; 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 and Reinforced Plastics and Electrical Insulating Materi-
2
als
1.1 This specification covers polycarbonate resin and pro-
D 792 Test Methods for Specific Gravity (Relative Density)
vides requirements and associated test methods for this ther-
2
and Density of Plastics by Displacement
moplastic when it is to be used in the manufacture of medical
2
D 883 Terminology Relating to Plastics
devices or components of medical devices.
D 955 Test Method of Measuring Shrinkage From Mold
1.2 As with any material, some characteristics may be
2
Dimensions of Molded Plastics
altered by the processing techniques (such as molding, extru-
D 1003 Test Method for Haze and Luminous Transmittance
sion, machining, assembly, sterilization, etc.) required for the
2
of Transparent Plastics
production of a specific part or device. Therefore, properties of
D 1238 Test Method for Flow Rates of Thermoplastics by
fabricated forms of this resin should be evaluated using those
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Extrusion Plastometer
test methods which are appropriate to assure safety and
D 1600 Terminology for Abbreviated Terms Relating to
efficacy.
2
Plastics
1.3 The properties included in this specification are those
2
D 1898 Practice for Sampling of Plastics
applicable for polycarbonate only. The biocompatibility of
3
D 3892 Practice for Packaging/Packing of Plastics
plastic compounds made up of polycarbonate resin containing
D 3935 Specification for Polycarbonate (PC) Unfilled and
colorants, fillers, processing aids, or other additives, as well as
3
Reinforced Materials
polymer blends which contain polycarbonate, should not be
F 748 Practice for Selecting Generic Biological Test Meth-
assumed. The biocompatibility of these modified polycarbon-
4
ods for Materials and Devices
ates must be established by testing the final (end-use) compo-
2.2 Underwriter’s Laboratories Document:
sitions using the appropriate methods of evaluation. In addi-
UL Standard 94 Tests and Flammability of Plastic Materials
tion, the biocompatibility of the material depends to a large
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for Parts in Devices and Appliances
degree on the nature of the end-use application. It is, therefore,
2.3 Other Document:
necessary to specify a set of biocompatibility test methods for
The United States Pharmacopeia
each new and distinct application.
1.4 This standard does not purport to address all of the
3. Significance and Use
safety concerns, if any, associated with its use. It is the
3.1 This specification is designed to recommend physical,
responsibility of the user of this standard to establish appro-
chemical, and biological test methods to establish a reasonable
priate safety and health practices and determine the applica-
level of confidence concerning the performance of unfilled
bility of regulatory limitations prior to use.
polycarbonate resins for use in medical devices. The properties
2. Referenced Documents listed should be considered in selecting material according to
the specific end-use requirements.
2.1 ASTM Standards:
D 256 Test Methods for Impact Resistance of Plastics and
4. Classification
2
Electrical Insulating Materials
2 4.1 Types of polycarbonate plastics, molding, and extrusion
D 570 Test Method for Water Absorption of Plastics
2 grades are described in Specification D 3935.
D 638 Test Method for Tensile Properties of Plastics
D 648 Test Method for Deflection Temperature of Plastics
5. General Requirements
2
Under Flexural Load
5.1 Polycarbonate resin may be processed by most tech-
D 790 Test Methods for Flexural Properties of Unreinforced
niques available for thermoplastic polymers. Medical devices
and components of medical devices made of polycarbonate
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This specification is under the jurisdiction of ASTM Committee F-4 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
3
F04.11 on Polymeric Materials. Annual Book of ASTM Standards, Vol 08.02.
4
Current edition approved October 10, 1998. Published March 1999. Originally Annual Book of ASTM Standards, Vol 13.01.
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published as F 997 – 86. Last previous edition F 997 – 98 . Available from Underwriter’s Laboratories, Publication Stock, 333 Pfingsten
2
Annual Book of ASTM Standards, Vol 08.01. Road, Northbrook, IL 60062.
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