ASTM International - ASTM F639-98a(2003)
Standard Specification for Polyethylene Plastics for Medical Applications
Organization: | ASTM International |
Publication Date: | 10 April 2003 |
Status: | inactive |
Page Count: | 4 |
ICS Code (Other standards related to laboratory medicine): | 11.100.99 |
ICS Code (Thermoplastic materials): | 83.080.20 |
scope:
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 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
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