ASTM F619-79(1997)e1 - 10.12.1997
 
1. 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.

 
2. Referenced Documents

D1193-06(2018)

Standard Specification for Reagent Water

D1239-22a

Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals (Includes all amendments and changes 9/12/2022).

USP

NF 24 or current edition Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.

D570-22

Standard Test Method for Water Absorption of Plastics

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

D543-21

Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents

D1898-68(1989)

Standard Practice for Sampling of Plastics (Withdrawn 1998)