ASTM F1906-98(2003)

    Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration (Withdrawn 2011)

    Withdrawn Standard: ASTM F1906-98(2003) | Developed by Subcommittee: F04.16

    WITHDRAWN, NO REPLACEMENT


      Format Pages Price  
    PDF 5 $50.40   ADD TO CART


    Withdrawn Rationale:

    This practice covers the introduction of a foreign substance into mammalian body that may induce the formation of an immune response. The immune response may lead to inadvertent tissue damage and be an undesirable event. In the standard protocols for biocompatibility testing, various studies in animals are done. These animals or their blood and tissues could be used to determine if immune responses have occurred and what types have occurred. At the current time, the immunologic testing in biocompatibility protocols is very limited. Techniques can be developed in the future which are simple, reliable, and sensitive.

    Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in March 2011 due to lack of support for its continuance.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 a foreign substance into mammalian body that may induce the formation of an immune response. The immune response may lead to inadvertent tissue damage and be an undesirable event. In the standard protocols for biocompatibility testing, various studies in animals are done. These animals or their blood and tissues could be used to determine if immune responses have occurred and what types have occurred. At the current time, the immunologic testing in biocompatibility protocols is very limited. Techniques can be developed in the future which are simple, reliable, and sensitive.

    1.2 It is the purpose of this practice to delineate some possible test methods. It must be remembered that these are protocols for use in biocompatibility testing, they are not diagnostic tests for evaluation of human conditions. Diagnostic test for use on humans must go through evaluation at the regulatory agencies. The tests described here are clearly adaptable for use in humans and can be used for research purposes and provide data in clinical trials, but are not necessarily cleared for diagnostic purposes. This practice presents selected methods. Other validated methods may be equally applicable.

    1.3 The values state 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.



    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

    F719 Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation

    F720 Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

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

    F763 Practice for Short-Term Screening of Implant Materials

    F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone


    DOI: 10.1520/F1906-98R03

    ASTM International is a member of CrossRef.