ASTM International - ASTM F1905-98(2003)

Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)

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Organization: ASTM International
Publication Date: 1 November 2003
Status: withdrawn
Page Count: 3
ICS Code (Laboratory medicine): 11.100
ICS Code (Protection against dangerous goods): 13.300
ICS Code (Test conditions and procedures in general): 19.020
scope:

1.1 This practice covers the introduction of foreign materials into the body that may have an impact on the immune system. One possible effect is that the immune system will be depressed or certain cell types may be affected. Immunotoxicity may be determined with blood and tissue samples from the animals used in the other biocompatibility test procedures such as implantation and blood contact test protocols. It is also possible to use these techniques with blood samples from human patients in a clinical trial. Any procedures with human subjects should follow the appropriate rules of the local institutional review board and the appropriate regulatory agencies. This document may serve as an annex to Practice F748.

1.2 The material may affect the humoral immune response, the cell mediated response, or both.

1.3 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.

abstract:

This practice covers the selection of tests for determining the propensity of materials used in medical devices to affect the immune system. That is, the foreign material introduced into the body... View More

Document History

ASTM F1905-98(2003)
November 1, 2003
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
1.1 This practice covers the introduction of foreign materials into the body that may have an impact on the immune system. One possible effect is that the immune system will be depressed or certain...
June 10, 1998
Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
1.1 This practice covers the introduction of foreign materials into the body that may have an impact on the immune system. One possible effect is that the immune system will be depressed or certain...
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