ASTM F619-02
Historical Standard: ASTM F619-02 Standard Practice for Extraction of Medical Plastics
SUPERSEDED (see Active link, below)
ASTM F619
1. Scope
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining 'extract liquid' for use in determining the biological response in preclinical testing. Further testing of the 'extract liquid' is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material 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 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D570 Test Method for Water Absorption of Plastics
D1193 Specification for Reagent Water
D1239 Test Method for Resistance of Plastic Films to Extraction by Chemicals
D1898 Practice for Sampling of Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
Other Documents
USP NF 24 or current edition Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.Keywords
biocompatibility; extraction; liquids; plastics; specimen size; Biocompatibility; Extraction methods; Material extracts (in biomedical materials); Plastic surgical devices/applications;
ICS Code
ICS Number Code 11.120.01 (Pharmaceutics in general); 83.080.01 (Plastics in general)
DOI: 10.1520/F0619-02
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