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Standard Practice for Subcutaneous Screening Test for Implant Materials (Includes all amendments And changes 12/31/2010).
Automatically translated name:
Standard Practice for Subcutaneous Screening Test for Implant Materials
STANDARD published on 10.11.1997
Designation standards: ASTM F1408-97(2002)e1
Note: WITHDRAWN
Publication date standards: 10.11.1997
SKU: NS-50173
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
Keywords:
biocompatibility, mice, orthopaedic medical devices, short-term tissue screening, subcutaneous tissue screening, tissue compatibility, toxicity/toxicology, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||
1.1 This practice provides a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals. The material may be dense or porous. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials. 1.2 This practice, along with other appropriate biological tests (including other ASTM test methods) may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to evaluate the effect of special surface textures and preparations of known materials. 1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. 1.4 The values stated in SI units are to be regarded as the standard. 1.5 This standard does not purport to address all of the safety problems, 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. |
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