ASTM-F1905 › Historical Revision Information
Selecting Tests for Determining the Propensity of Materialsto Cause Immunotoxicity, Stand
The following bibliographic material is provided to assist you with your purchasing decision:
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.
Keywords
B cells; biocompatibility; cell mediated immunity; complement; humoral immunity; immunotoxicity; T cells; ICS Number Code 11.100 (Laboratory medicine); 13.300 (Protection against dangerous goods); 19.020 (Test conditions and procedures in general)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
19.020 (Test conditions and procedures in general)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Document Number
ASTM-F1905
Revision Level
WITHDRAWN
Status
Cancelled
Modification Type
New
Publication Date
Jan. 1, 2011
Document Type
Practice
Committee Number
F04.16