ASTM F 1408 : 1997 : R2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Standard Practice for Subcutaneous Screening Test for Implant Materials
Hardcopy , PDF
01-09-2020
English
01-10-2013
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 13.01, 2015 Defines a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals.
| Committee |
F 04
|
| DocumentType |
Standard Practice
|
| Pages |
5
|
| ProductNote |
Reconfirmed 2013
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
1.1This practice covers 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.
1.2This 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.
1.3This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5This 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.
| ASTM F 748 : 2016 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ASTM F 2066 : 2018 | Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) |
| ASTM F 1983 : 2014 | Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
| ASTM F 86 : 2013 : REDLINE | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
| ASTM F 136 : 2013 : REDLINE | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| ASTM F 648 : 2014 : REDLINE | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
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