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. |
Title 21 | CFR Subpart 177.1580 Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS. |
UL Standard 94 | 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. |
D1600-18 | Standard Terminology for Abbreviated Terms Relating to Plastics (Withdrawn 2024) |
ISO 10993 | 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. |
F748-16 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
D3935-21 | Standard Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material |
D3892-15(2020) | Standard Practice for Packaging/Packing of Plastics |
D1898-68(1989) | Standard Practice for Sampling of Plastics (Withdrawn 1998) |
D1238-23a | Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023). |
D1003-21 | Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics |
D955-21 | Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics |
D883-24 | Standard Terminology Relating to Plastics |
D792-20 | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
D790-17 | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
D570-22 | Standard Test Method for Water Absorption of Plastics |
D256-23e1 | Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics (Includes all amendments and changes 4/7/2023). |
D648-18 | Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position |
D638-22 | Standard Test Method for Tensile Properties of Plastics |
|