ASTM-F1439 › Historical Revision Information
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
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Scope
1.1 This guide is intended to assist the biomaterials testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for new materials to evoke a neoplastic response. The procedure is generally reserved only for those materials which have not previously been used for human implantation for a significant period of time.
1.2 Assessment of tumorigenicity is one of several procedures employed in determining the biological response to a material as recommended in Practice F 748
1.3 Whenever possible, it is recommended that a battery of genotoxicity procedures be initiated and proposed as an alternative to an in-vivo tumorigenicity bioassay. Genotoxicity assays may also be considered as initial screening procedures due to the sensitivity of the assays, the significant reduction in time to gain valuable data, and the desire to reduce the use of animals for testing. Genotoxicity assays that may be considered are outlined in Guides E 1262, E 1263, E 1280, and E 2186
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.
Significance and Use
This guide is not intended to specify the exact method of conducting a test for any particular material but only to present some of the criteria that should be considered in method design and possible problems that could lead to misleading results. In the development of the actual test protocol, it is recommended that recognized tumorigenesis bioassay procedures be consulted.
The recommendations given in this guide may not be appropriate for all applications or types of implant materials. These recommendations should be utilized by experienced testing personnel in conjunction with other pertinent information and the requirements of the specific material application.
Keywords
biocompatibility; carcinogenicity testing; tumorigenicity testing; Biocompatibility; Biomedical materials/applications; Neoplastic response; Performance--surgical materials/applications; Rats; Test animals; Tumoreigenic potential; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
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13.01 (Medical and Surgical Materials and Devices)
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Document Number
ASTM-F1439-03(2008)
Revision Level
2003 R08 EDITION
Status
Superseded
Modification Type
Reapproval
Publication Date
Aug. 1, 2008
Document Type
Guide
Page Count
6 pages
Committee Number
F04.16