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ASTM International - ASTM F639-09(2015)

Standard Specification for Polyethylene Plastics for Medical Applications

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Organization: ASTM International
Publication Date: 1 March 2015
Status: active
Page Count: 3
ICS Code (Other standards related to laboratory medicine): 11.100.99
ICS Code (Thermoplastic materials): 83.080.20
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... View More

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.

abstract:

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... View More

Document History

ASTM F639-09(2015)
March 1, 2015
Standard Specification for Polyethylene Plastics for Medical Applications
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...
August 1, 2009
Standard Specification for Polyethylene Plastics for Medical Applications
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...
April 10, 2003
Standard Specification for Polyethylene Plastics for Medical Applications
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....
October 10, 1998
Standard Specification for Polyethylene Plastics for Medical Applications
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...
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