ASTM-F639 › Standard Specification for Polyethylene Plastics for Medical Applications
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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.
Scope
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.
Significance and Use
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.
Keywords
 plastic surgical devices/applications; polyethylene (PE) plastics—surgical implant applications; polymers—surgical applications ;; ICS Number Code 11.100.99 (Other standards related to laboratory medicine); 83.080.20 (Thermoplastic materials)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.100.99 (Other standards related to laboratory medicine)
11.120.01 (Pharmaceutics in general)
83.080.20 (Thermoplastic materials)
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Document Number
ASTM-F639-09(2015)
Revision Level
2009 R15 EDITION
Status
Current
Modification Type
Reapproval
Publication Date
May 1, 2015
Document Type
Specification
Page Count
3 pages
Committee Number
F04.11