ASTM F639-09(2015) PDF

Scope: X1.2 Significance

X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.

1.1 This 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.

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

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 and health practices and determine the applicability of regulatory limitations prior to use.

ASTM F639-09(2015) Referenced Document

ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
ASTM D1898
ASTM D4976 Standard specifications for polyethylene plastic molding and extrusion materials*， 2024-04-20 Update
ASTM D638 Standard Test Method for Tensile Properties of Plastics
ASTM D671 Standard test method and practice guide for evaluating fleece floor coverings
ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
ASTM D747 Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-20 Update
ASTM D883 Standard Terminology Relating to Plastics
ASTM E117
ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

2009 ASTM F639-09(2015) Standard Specification for Polyethylene Plastics for Medical Applications
2009 ASTM F639-09 Standard Specification for Polyethylene Plastics for Medical Applications
1998 ASTM F639-98a(2003) Standard Specification for Polyethylene Plastics for Medical Applications
1998 ASTM F639-98a Standard Specification for Polyethylene Plastics for Medical Applications