ASTM F997-18

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F997 − 10 F997 − 18
Standard Specification for
Polycarbonate Resin for Medical Applications
This standard is issued under the fixed designation F997; 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 (´) indicates an editorial change since the last revision or reapproval.
1. 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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2.1 ASTM Standards:
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 (Withdrawn 1998)
D3892 Practice for Packaging/Packing of Plastics
D3935 Classification System and Basis for Specification for Polycarbonate (PC) Unfilled and Reinforced Material
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.11 on Polymeric Materials.
Current edition approved Jan. 1, 2010Dec. 1, 2018. Published January 2010February 2019. Originally approved in 1986. Last previous edition approved in 20032010 as
F997 – 98aF997 – 10.(2003). DOI: 10.1520/F0997-10. 10.1520/F0997-18.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F997 − 18
2.2 Underwriter’s Laboratories Document:
UL Standard 94 Tests andfor Flammability of Plastic Materials for Parts in Devices and Appliances
2.3 Code of Federal Regulations:
Title 21 CFR Subpart 177.1580 Polycarbonate Resins
2.4 ISO Standard:
ISO 1099310993-1 Biological Evaluation of Medical DevicesDevices—Part 1: Evaluation and testing within a risk management
process
3. Significance and Use
3.1 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level
of confidence concerning the performance of unfilled polycarbonate resins for use in medical devices. The properties listed should
be considered in selecting material according to the specific end-use requirements.
4. Classification
4.1 Types of polycarbonate plastics, molding, and extrusion grades are described in Specification ASTM Standard D3935.
5. General Requirements
5.1 Polycarbonate resin may be processed by most techniques available for thermoplastic polymers. Medical devices and
components of medical devices made of polycarbonate may be sterilized. Methods used successfully include steam, ethylene oxide,
and irradiation. Repeated sterilization may weaken parts molded ofmade from any plastic material. The number of times a given
part may be sterilized safely without fear of subsequent breakage depends on a number of factors, for example, the design of the
part, the method of manufacture, the method of sterilization, and the application or use of the part. Therefore, it is imperative that
the manufacturer test the part to determine the maximum number of sterilization cycles to which it can be safely subjected. The
function of the part should be very carefully evaluated if repeated sterilization
...