Standard Specification for Polyethylene Plastics for Medical Applications

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-03-2015

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Defines 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.

1.1This specification covers polyethylene plastics (as defined in Terminology D883) 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.

1.2This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.

1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4This 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.

Committee	F 04
DocumentType	Standard
Pages	3
ProductNote	Reconfirmed 2015
PublisherName	American Society for Testing and Materials
Status	Current

ASTM D 883 : 2023	Standard Terminology Relating to Plastics
ASTM D 1238 : 2000	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1238 : 2004 : REV C	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 671 : 1993	Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
ASTM D 1238 : 2023	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1238 : 2023 : REV A	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 4976 : 2006	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 1238 : 2013	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 4976 : 2000 : REV B	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 883 : 2024	Standard Terminology Relating to Plastics
ASTM D 1238 : 2010	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 4976 : 2004 : REV A	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 4976 : 2004	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 883 : 2022	Standard Terminology Relating to Plastics
ASTM D 883 : 2020 : REV B	Standard Terminology Relating to Plastics
ASTM D 1238 : 2013 : REDLINE	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1505 : 2003	Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 4976 : 2012	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 4976 : 2012 : REV A : R2020	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 4976 : 2002	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 1898 : 1968 : R1989	Standard Practice for Sampling of Plastics (Withdrawn 1998)
ASTM E 117 : 1964 : R1989	Method for Spectrographic Analysis of Pig-Lead by the Point-To-Plane Technique (Withdrawn 1995)
ASTM D 638 : 2014	Standard Test Method for Tensile Properties of Plastics
ASTM D 1238 : 2004	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1505 : 1968 : R1979	Standard Test Method for Density Of Plastics By The Density-Gradient Technique
ASTM D 790 : 2017 : REDLINE	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM F 748 : 2016 : REDLINE	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 1505 : 2010	Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 1505 : 2018	Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 695 : 2015	Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D 4976 : 2002 : EDT 1	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 1505 : 1998 : EDT 1	Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D 1238 : 2001 : EDT 1	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 695 : 2015 : REDLINE	Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D 1238 : 2020	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 1238 : 2004 : REV A	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 695 : 2023	Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D 638 : 2014 : REDLINE	Standard Test Method for Tensile Properties of Plastics
ASTM D 1238 : 1985	Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D 4976 : 2012 : REV A	Standard Specification for Polyethylene Plastics Molding and Extrusion Materials
ASTM D 638 : 2022	Standard Test Method for Tensile Properties of Plastics