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ASTM F 3268 : 2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Standard Guide for in vitro Degradation Testing of Absorbable Metals

Available format(s)

Hardcopy , PDF

Superseded date

13-11-2018

Language(s)

English

Published date

01-04-2018

$135.86
Including GST where applicable

CONTAINED IN VOL. 13.02, 2018 Specifies experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids.

Committee
F 04
DocumentType
Guide
Pages
13
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

1.1The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.

1.2The described experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material is also incorporated to facilitate comparison and normalization of results across laboratories.

1.3The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated device. The described tests may also be utilized to define a device’s performance threshold prior to more extensive in vitro performance evaluations (e.g. fatigue testing) or in vivo evaluations.

1.4This standard is considered to be applicable to all absorbable metals, including magnesium, iron, and zinc-based metals and alloys.

1.5The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid or slower degradation rate than an absorbable metal’s actual in vivo corrosion rate. The herein described test methods are to be used for material comparison purposes only and are not to act as either a predictor or substitute for evaluation of the in vivo degradation properties of a device.

1.6This standard only provides guidance regarding the in vitro degradation of absorbable metals and does not address any aspect regarding either in vivo or biocompatibility evaluations.

1.7This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM G 59 : 1997 Standard Test Method for Conducting Potentiodynamic Polarization Resistance Measurements
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ASTM F 3160 : 2016 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
ASTM E 2375 : 2016 : REDLINE Standard Practice for Ultrasonic Testing of Wrought Products
ASTM B 943 : 2016 : REDLINE Standard Specification for Zinc and Tin Alloy Wire Used in Thermal Spraying for Electronic Applications
ASTM G 46 : 1994 : R2018 Standard Guide for Examination and Evaluation of Pitting Corrosion
ASTM F 2739 : 2016 Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds
DIN 50918:1978-06 CORROSION OF METALS; ELECTROCHEMICAL CORROSION TESTS
ASTM G 4 : 2001 Standard Guide for Conducting Corrosion Tests in Field Applications
ASTM G 3 : 2014 Standard Practice for Conventions Applicable to Electrochemical Measurements in Corrosion Testing
ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ASTM B 954 : 2015 : REDLINE Standard Test Method for Analysis of Magnesium and Magnesium Alloys by Atomic Emission Spectrometry

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