ASTM F 639 : 2009 : R2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Specification for Polyethylene Plastics for Medical Applications
Hardcopy , PDF
20-05-2024
English
06-05-2015
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
F 04
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| DocumentType |
Standard
|
| Pages |
3
|
| ProductNote |
Reconfirmed 2015
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| PublisherName |
American Society for Testing and Materials
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| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| 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 |
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