ASTM F639-98a(2003)
Historical Standard: ASTM F639-98a(2003) Standard Specification for Polyethylene Plastics for Medical Applications
SUPERSEDED (see Active link, below)
ASTM F639
1. Scope
1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) intended for use in medical device applications involving human tissue contact devices, short term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.
1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.
1.3 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.
ASTM Standards
D638 Test Method for Tensile Properties of Plastics
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D695 Test Method for Compressive Properties of Rigid Plastics
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883 Terminology Relating to Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1898 Practice for Sampling of Plastics
D4976 Specification for Polyethylene Plastics Molding and Extrusion Materials
E117 Method for Spectrographic Analysis of Pig Lead by the Point-to-Plane Technique
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO Standard
ISO10993 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.Keywords
plastic surgical devices/applications; polyethylene (PE) plastics surgical implant applications; polymers surgical applications; Plastic surgical devices/applications--specifications; Polyethylene (PE) surgical implant applications--specifications; Polymers (surgical applications)--specifications;
ICS Code
ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.20 (Thermoplastic materials)
DOI: 10.1520/F0639-98AR03
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