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ASTM F 1905 : 1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

06-10-1998

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2009 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.

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.

Committee
F 04
DocumentType
Standard Practice
Pages
3
ProductNote
Reconfirmed 1998
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

ASTM F 2103 : 2018 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
ASTM F 2064 : 2017 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM F 2315 : 2018 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
ASTM F 1983 : 2014 Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
ASTM F 2212 : 2011 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

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PDF - English
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