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ASTM F997-98a(2003)

(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.

General Information

Status
Historical
Publication Date
09-Apr-2003
ICS
11.100.99 - Other standards related to laboratory medicine
83.080.20 - Thermoplastic materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F997-98ae1 - Standard Specification for Polycarbonate Resin for Medical Applications
Effective Date
10-Apr-2003
Replaced By
ASTM F997-10 - Standard Specification for Polycarbonate Resin for Medical Applications
Effective Date
01-Jan-2010
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Apr-2003

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

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