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ASTM F 619 : 2003

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Standard Practice for Extraction of Medical Plastics

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-11-2003

€59.22
Excluding VAT

Committee
F 04
DocumentType
Standard Practice
Pages
4
ProductNote
Reconfirmed 2003
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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.

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