ASTM F997-18
Standard Specification for Polycarbonate Resin for Medical Applications

Standard No.

ASTM F997-18

Release Date

2018

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F997-18

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F997-18 Referenced Document

• ASTM D1003 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
• ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
• ASTM D1600 Standard Terminology for Abbreviated Terms Relating to Plastics
• ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics*， 2023-03-15 Update
• ASTM D3892 Standard Practice for Packaging/Packing of Plastics
• ASTM D3935 Standard Specification for Polycarbonate (PC) Unfilled and Reinforced Material
• ASTM D570 Standard Test Method for Water Absorption of Plastics
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D648 Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position*， 2024-04-21 Update
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-21 Update
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• ASTM D883 Standard Terminology Relating to Plastics*， 2024-02-01 Update
• ASTM D955 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

ASTM F997-18 history

• 2018 ASTM F997-18 Standard Specification for Polycarbonate Resin for Medical Applications
• 2010 ASTM F997-10 Standard Specification for Polycarbonate Resin for Medical Applications
• 1998 ASTM F997-98a(2003) Standard Specification for Polycarbonate Resin for Medical Applications
• 1998 ASTM F997-98ae1 Standard Specification for Polycarbonate Resin for Medical Applications
• 1998 ASTM F997-98a Standard Specification for Polycarbonate Resin for Medical Applications