ASTM E2537-08
ASTM E2891-13
ASTM F619-14
ASTM F624-09
ASTM F639-09
ASTM F640-12
Cookies
Wir benötigen Ihre Einwilligung zur Verwendung der einzelnen Daten, damit Sie unter anderem Informationen zu Ihren Interessen einsehen können. Klicken Sie auf "OK", um Ihre Zustimmung zu erteilen.
ASTM F997-10
Standard Specification for Polycarbonate Resin for Medical Applications
Automatische name übersetzung:
Standard-Spezifikation für Polycarbonatharz für die Medizintechnik
NORM herausgegeben am 1.1.2010
Informationen über die Norm:
Bezeichnung normen: ASTM F997-10
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.1.2010
SKU: NS-57213
Zahl der Seiten: 3
Gewicht ca.: 9 g (0.02 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Kategorie - ähnliche Normen:
Other standards related to laboratory medicineThermoplastic materials
Die Annotation des Normtextes ASTM F997-10 :
Keywords:
plastics (thermoplastic), plastic surgical devices/applications, polycarbonate (PC) plastics, polymers-surgical applications, resins-polycarbonate, seals, Plastic surgical devices/applications--specifications, Polycarbonate (PC)--specifications, Polymers (surgical applications)--specifications, Seals--surgical implant applications, Surgical implant resins--specifications, Thermoplastic surgical implant applications--specifications
Ergänzende Informationen
| 1. Scope | ||||||||||||||||||||||||||||||||||||
|
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. |
||||||||||||||||||||||||||||||||||||
| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||
|
Ähnliche Normen:
Historisch
1.1.2008
Historisch
1.11.2013
Historisch
1.3.2014
Historisch
1.8.2009
Historisch
1.8.2009
Historisch
15.12.2012
Empfehlungen:
Aktualisierung der technischen Normen
Wollen Sie sich sicher sein, dass Sie nur die gültigen technischen Normen verwenden?
Wir bieten Ihnen eine Lösung, die Ihnen eine Monatsübersicht über die Aktualität der von Ihnen angewandten Normen sicher stellt.
Brauchen Sie mehr Informationen? Sehen Sie sich diese Seite an.
