ASTM-F1408 Standard Practice for Subcutaneous Screening Test for Implant Materials

ASTM-F1408 - 2020A EDITION - CURRENT
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Standard Practice for Subcutaneous Screening Test for Implant Materials
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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.

Keywords

Biocompatibility; Mouse/mice; Orthopaedic medical devices; Short-term tissue screening; Subcutaneous tissue screening; Tissue compatibility; Toxicity/toxicology

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F1408-20A

Revision Level

2020A EDITION

Status

Current

Modification Type

Revision

Publication Date

Sept. 1, 2020

Document Type

Practice

Page Count

5 pages

Committee Number

F04.16