ASTM-F639 2009
$35.75
F639-09 Standard Specification for Polyethylene Plastics for Medical Applications
| Published By | Publication Date | Number of Pages |
| ASTM | 2009 | 3 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | Scope Referenced Documents Significance Classification General Requirements |
| 2 | Sampling Physical Methods Packaging and Labeling Biocompatibility Keywords X1. SUGGESTED PRACTICE FOR EXTRACTABLE METALS ANALYSIS OF PLASTIC BY ATOMIC ABSORPTION SPECTROSCOPY X1.1 Scope X1.2 Significance X1.3 Preparation of Specimens |
| 3 | X1.4 Preparation of Extract Solution X1.5 Preparation of Atomic Absorption Standards X1.6 Procedure X1.7 Calculation X1.8 Precision and Accuracy X2. BIOCOMPATIBILITY X2.1 X2.2 |
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