ASTM F1905-98(2003)

    Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)

    Withdrawn Standard: ASTM F1905-98(2003) | Developed by Subcommittee: F04.16

    WITHDRAWN, NO REPLACEMENT


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    Withdrawn Rationale:

    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.

    Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in March 2011 due to lack of support for its continuance.

    1. 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.



    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    F619 Practice for Extraction of Medical Plastics

    F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices


    Referencing This Standard

    DOI: 10.1520/F1905-98R03

    ASTM International is a member of CrossRef.

    Citation Format

    ASTM F1905-98(2003), Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011), ASTM International, West Conshohocken, PA, 2003, www.astm.org

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