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ASTM F639-09

Current Revision

Standard Specification for Polyethylene Plastics for Medical Applications

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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 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.

This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.


Significance

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X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metals 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.

SDO ASTM: ASTM International
Document Number F639
Publication Date Aug. 1, 2009
Language en - English
Page Count 3
Revision Level 09
Supercedes
Committee F04.11
Publish Date Document Id Type View
Aug. 1, 2009 F0639-09 Revision
Oct. 10, 1998 F0639-98A Revision
May 1, 2024 F0639-09R24 Reaffirmation
March 1, 2015 F0639-09R15 Reaffirmation
April 10, 2003 F0639-98AR03 Reaffirmation