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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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardISO10993 Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Code of Federal RegulationsTitle21 CFR Subpart 177.1580 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
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
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
Underwriters Laboratories DocumentULStandard94 Tests and Flammability of Plastic Materials for Parts in Devices and Appliances Available from Underwriters Laboratories (UL), 333 Pfingsten Rd., Northbrook, IL 60062-2096, http://www.ul.com.
ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.20 (Thermoplastic materials); 11.100.99 (Other standards related to laboratory medicine)
UNSPSC Code 13111012(Polycarbonate resin)