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  • ASTM
    F619-14 Standard Practice for Extraction of Medical Plastics
    Edition: 2014
    $144.00
    Unlimited Users per year

Description of ASTM-F619 2014

ASTM F619-14

Historical Standard: Standard Practice for Extraction of Medical Plastics




ASTM F619

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 1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids.

1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

1.5 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.


Keywords

biocompatibility; extraction; liquids; plastics; specimen size


ICS Code

ICS Number Code 11.100.99 (Other standards related to laboratory medicine)


DOI: 10.1520/F0619-14



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