ASTM F997-98ae1

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

• Replaces: ASTM F997-98a - Standard Specification for Polycarbonate Resin for Medical Applications
• Effective Date: 10-Oct-1998
• Replaced By: ASTM F997-98a(2003) - Standard Specification for Polycarbonate Resin for Medical Applications
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Oct-1998

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
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Designation: F 997 – 98a
Standard Specification for
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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.
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e NOTE—Editorial corrections were made to 2.3 and 6.1 in May 2001.
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1. Scope Under Flexural Load
D 790 Test Methods for Flexural Properties of Unreinforced
1.1 This specification covers polycarbonate resin and pro-
and Reinforced Plastics and Electrical Insulating Materi-
vides requirements and associated test methods for this ther-
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als
moplastic when it is to be used in the manufacture of medical
D 792 Test Methods for Specific Gravity (Relative Density)
devices or components of medical devices.
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and Density of Plastics by Displacement
1.2 As with any material, some characteristics may be
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D 883 Terminology Relating to Plastics
altered by the processing techniques (such as molding, extru-
D 955 Test Method of Measuring Shrinkage From Mold
sion, machining, assembly, sterilization, and so forth) required
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Dimensions of Molded Plastics
for the production of a specific part or device. Therefore,
D 1003 Test Method for Haze and Luminous Transmittance
properties of fabricated forms of this resin should be evaluated
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of Transparent Plastics
using those test methods that are appropriate to assure safety
D 1238 Test Method for Flow Rates of Thermoplastics by
and efficacy.
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Extrusion Plastometer
1.3 The properties included in this specification are those
D 1600 Terminology for Abbreviated Terms Relating to
applicable for polycarbonate only. The biocompatibility of
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Plastics
plastic compounds made up of polycarbonate resin containing
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D 1898 Practice for Sampling of Plastics
colorants, fillers, processing aids, or other additives, as well as
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D 3892 Practice for Packaging/Packing of Plastics
polymer blends which contain polycarbonate, should not be
D 3935 Specification for Polycarbonate (PC) Unfilled and
assumed. The biocompatibility of these modified polycarbon-
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Reinforced Materials
ates must be established by testing the final (end-use) compo-
F 748 Practice for Selecting Generic Biological Test Meth-
sitions using the appropriate methods of evaluation. In addi-
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ods for Materials and Devices
tion, the biocompatibility of the material depends to a large
2.2 Underwriter’s Laboratories Document:
degree on the nature of the end-use application. It is, therefore,
UL Standard 94 Tests and Flammability of Plastic Materials
necessary to specify a set of biocompatibility test methods for
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for Parts in Devices and Appliances
each new and distinct application.
2.3 Code of Federal Regulations:
1.4 This standard does not purport to address all of the
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Title 21 CFR Subpart 177.1580
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Significance and Use
priate safety and health practices and determine the applica-
3.1 This specification is designed to recommend physical,
bility of regulatory limitations prior to use.
chemical, and biological test methods to establish a reasonable
2. Referenced Documents level of confidence concerning the performance of unfilled
polycarbonate resins for use in medical devices. The properties
2.1 ASTM Standards:
listed should be considered in selecting material according to
D 256 Test Methods for Impact Resistance of Plastics and
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the specific end-use requirements.
Electrical Insulating Materials
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D 570 Test Method for Water Absorption of Plastics
4. Classification
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D 638 Test Method for Tensile Properties of Plastics
4.1 Types of polycarbonate plastics, molding, and extrusion
D 648 Test Method for Deflection Temperature of Plastics
grades are described in Specification D 3935.
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This specification is under the jurisdiction of ASTM Committee F04 on Annual Book of ASTM Standards, Vol 08.02.
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Medical and Surgical Materials and Devices and is the direct responsibility of Annual Book of ASTM Standards, Vol 13.01.
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Subcommittee F04.11 on Polymeric Materials. Available from Underwriter’s Laboratories, Publication Stock, 333 Pfingsten
Current edition approved October 10, 1998. Published March 1999. Originally Rd., Northbrook, IL 60062.
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published as F 997 – 86. Last previous edition F 997 – 98 . Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
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Annual Book of ASTM Standards, Vol 08.01. Robbins Ave., Philadelphia, PA 19111–5094, Attn: NPODS.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
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