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ASTM F997-98ae1
Standard Specification for Polycarbonate Resin for Medical Applications (Includes all amendments And changes 8/16/2017).
Automatische name übersetzung:
Standard-Spezifikation für Polycarbonatharz für die Medizintechnik
NORM herausgegeben am 10.10.1998
Informationen über die Norm:
Bezeichnung normen: ASTM F997-98ae1
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 10.10.1998
SKU: NS-57216
Zahl der Seiten: 3
Gewicht ca.: 9 g (0.02 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Die Annotation des Normtextes ASTM F997-98ae1 :
Keywords:
plastics (thermoplastic), plastic surgical devices/applications, polycarbonate (PC) plastics, polymers-surgical applications, resins-polycarbonate, seals
Ergänzende Informationen
| 1. Scope | ||||||||||||||||||||||||||||||||||||
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1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy. 1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application. 1.4 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. |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||
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