UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ASTM International - ASTM F619-14

Standard Practice for Extraction of Medical Plastics

inactive
Buy Now
Organization: ASTM International
Publication Date: 1 March 2014
Status: inactive
Page Count: 4
ICS Code (Other standards related to laboratory medicine): 11.100.99
ICS Code (Plastics in general): 83.080.01
significance And Use:

5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices.

5.2 The limitations of the... View More

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.

Document History

August 1, 2020
Standard Practice for Extraction of Materials Used in Medical Devices
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices. 5.2 The limitations of...
ASTM F619-14
March 1, 2014
Standard Practice for Extraction of Medical Plastics
5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices. 5.2 The limitations of the results...
August 1, 2008
Standard Practice for Extraction of Medical Plastics
These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices. The limitations of the results obtained from...
November 1, 2003
Standard Practice for Extraction of Medical Plastics
These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices. The limitations of the results obtained from...
April 10, 2002
Standard Practice for Extraction of Medical Plastics
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...
December 10, 1997
Standard Practice for Extraction of Medical Plastics
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...
Advertisement