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

ASTM-F1408 - 1997 R13 EDITION - CURRENT
Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Standard Practice for Subcutaneous Screening Test for Implant Materials
ORDER

Price:

$46.00        

Scope

1.1 This 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.

1.2 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 standard. No other units of measurement are included in this standard.

1.5 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.

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)

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)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ASTM-F1408-97(2013)

Revision Level

1997 R13 EDITION

Status

Current

Modification Type

Reapproval

Publication Date

Nov. 1, 2013

Document Type

Practice

Page Count

5 pages

Committee Number

F04.16