Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials

Importancia y uso:

4.1 This guide is not intended to specify the exact method of conducting a test for any particular material or final, finished device 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 alternatives to animal testing be considered as appropriate. If tumor bioassays are considered necessary, experimental design should include valid methods3 and an adequate number of animals should be included for meaningful statistical evaluation of the data.

4.2 The recommendations given in this guide may not be appropriate for all applications, types of implant materials, or all medical devices. These recommendations should be utilized by experienced testing personnel in conjunction with other pertinent information and the requirements of the specific application.

Subcomité:

F04.16

Referida por:

F2064-17, F0748-16, F2103-18, F2347-24, E3219-20, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

biocompatibility; carcinogenicity testing; tumorigenicity testing;