Document Center is acquired by Nimonik

Scope

1.1 This practice covers methods for extraction of medical plastics in liquids that simulate body fluids in their action on the plastics. This practice identifies two methods of extraction: one used for obtaining "extract liquid" to be analyzed by chemical and physical tests; and the other obtaining "extract liquid" for use in determining the biological response of animals. Further testing of the "extract liquid" is specified in other ASTM standards. The plastic after extraction may also be examined.

1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.

1.3 The values stated in SI units are to be regarded as the standard.

1.4 This standard does not purport to address all of the safety problems, 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.

Keywords

Biocompatibility; Extraction methods; Material extracts (in biomedical materials); Plastic surgical devices/applications; extraction of medical plastics (in liquids simulating bodily fluids),; practice; ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.01 (Plastics in general)

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)

83.080.01 (Plastics in general)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.