ASTM International - ASTM F639-09
Standard Specification for Polyethylene Plastics for Medical Applications
| Organization: | ASTM International |
| Publication Date: | 1 August 2009 |
| Status: | inactive |
| Page Count: | 3 |
| ICS Code (Pharmaceutics in general): | 11.120.01 |
| ICS Code (Thermoplastic materials): | 83.080.20 |
significance And Use:
Significance
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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 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.
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
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