ASTM F602-98a

Standard Criteria for Implantable Thermoset Epoxy Plastics (Includes all amendments And changes 8/16/2017).

Automatically translated name:

Standard Criteria for Implantable Thermoset Epoxy Plastics

STANDARD published on 10.10.1998

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The information about the standard:

Designation standards: ASTM F602-98a
Note: WITHDRAWN
Publication date standards: 10.10.1998
SKU: NS-55845
The number of pages: 4
Approximate weight : 12 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F602-98a :

Keywords:

Epoxy (EP) plastics-surgical implants, Epoxy resins, Plastics (thermosetting), Plastic surgical devices/applications, Polymers-surgical applications, Resins-epoxy, implantable thermoset epoxy plastics, criteria

Additional information

1. Scope

1.1 These 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.

1.2 These 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.

1.3 Compliance 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.

1.4 Each 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.

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

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

1.7 The 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.

2. Referenced Documents

D792-20	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D952-15(2021)	Standard Test Method for Bond or Cohesive Strength of Sheet Plastics and Electrical Insulating Materials
ISO 10993	Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
D149-20	Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
D1042-22	Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture
D1434-23	Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1763-00(2021)	Standard Specification for Epoxy Resins
D2393-86	Test Method for Viscosity of Epoxy Resins and Related Components
D2471-99	Standard Test Method for Gel Time and Peak Exothermic Temperature of Reacting Thermosetting Resins (Withdrawn 2008)
D2562-94(2015):2015/ADJD2562	Adjunct to D2562 Practice for Classifying Visual Defects in Parts Molded from Reinforced Thermosetting Plastics
D2734-23	Standard Test Methods for Void Content of Reinforced Plastics
D3137-81(2018)	Standard Test Method for Rubber Property´Hydrolytic Stability
E96/E96M-23	Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
F74-73(1989)	Practice for Determining Hydrolytic Stability of Plastic Encapsulants for Electronic Devices (Withdrawn 1994)
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
EOS-D	10/75 Standard for Ethylene Oxide Sterilization Available from the Association for the Advancement of Medical Instrumentation, 1901 N. Ft. Myer Dr., Suite 602, Arlington, VA 22209.
D150-22	Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
D257-14(2021)e1	Standard Test Methods for DC Resistance or Conductance of Insulating Materials (Includes all amendments and changes 5/6/2021).
D570-22	Standard Test Method for Water Absorption of Plastics
D621-64(1988)	Test Methods for Deformation of Plastics Under Load (Withdrawn 1994)
D638-22	Standard Test Method for Tensile Properties of Plastics
D785-23	Standard Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials

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