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ASTM F602-98a
Standard Criteria for Implantable Thermoset Epoxy Plastics (Includes all amendments And changes 8/16/2017).
Automatische name übersetzung:
Standard Kriterien für implantierbare Thermoset Plastics Epoxy
NORM herausgegeben am 10.10.1998
Informationen über die Norm:
Bezeichnung normen: ASTM F602-98a
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 10.10.1998
SKU: NS-55845
Zahl der Seiten: 4
Gewicht ca.: 12 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Die Annotation des Normtextes 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
Ergänzende Informationen
| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||
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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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||
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