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ASTM F 602 : 2009 : R2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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 Criteria for Implantable Thermoset Epoxy Plastics

Available format(s)

Hardcopy , PDF

Superseded date

11-07-2024

Language(s)

English

Published date

01-11-2014

€59.22
Excluding VAT

CONTAINED IN VOL. 13.01, 2015 Specifies thermoset plastics based on diglycidyl ethers of bisphenol A (DGEBPA) and appropriate curing agents or catalysts as opposed to thermoplastics based on epoxy structures.

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy

1.1These criteria cover thermoset plastics based on diglycidyl ethers of bisphenol A (DGEBPA) and appropriate curing agents or catalysts as opposed to thermoplastics based on epoxy structures.

1.2These criteria are generic and are intended to provide definitions and a standard description of epoxy plastics used in implantable devices. It is also intended to serve as a standard guide for the preparation of more specific documents with values and limits covering specific end uses.

1.3Compliance with these criteria shall not be construed as an endorsement of implantability. The biocompatibility of epoxy plastics as a class has not been established. Epoxy plastic is a generic term relating to the class of polymers formed from epoxy resins, certain curing agents or catalysts, and various additives. Since many compositions and formulations fall under this class, it is essential that the formulator or fabricator ensure biocompatibility of the specific composition or formulation in its intended end use. Since these criteria provide guidance for the preparation of more specific documents covering specific end uses, these documents will provide bases for standardized evaluation of biocompatibility appropriate for a specific end use.

1.4Each of the properties listed shall be considered in selecting materials for specific end uses. A list of selected properties with limiting values assigned is suggested for separate product specifications.

1.5All of the properties and test methods listed may not be pertinent in any specific situation, nor may all of the tests outlined be required.

1.6These criteria are limited to functionally or fully cured epoxy plastics. Uncured or incompletely cured formulations are specifically excluded.

1.7The epoxy plastics covered by this standard are those to be evaluated for use in implantable biomedical devices. The term implantable is herein considered to include devices used in vivo for time periods in excess of 30 days.

1.8This 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.

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ASTM D 2393 : 1986 Test Method for Viscosity of Epoxy Resins and Related Components
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ASTM D 3137 : 1981 : R2018 Standard Test Method for Rubber Property—Hydrolytic Stability
ASTM D 257 : 2014 : REDLINE Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ASTM D 2562 : 1994 Standard Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics

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