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ASTM F997-98a(2003)
Standard Specification for Polycarbonate Resin for Medical Applications (Includes all amendments And changes 12/31/2010).
Automaticky preložený názov:
Štandardné špecifikácie pre polykarbonátová živica na lekárske účely
NORMA vydaná dňa 10.4.2003
Informácie o norme:
Označenie normy: ASTM F997-98a(2003)
Poznámka: NEPLATNÁ
Dátum vydania normy: 10.4.2003
Kód tovaru: NS-57214
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM F997-98a(2003) :
Keywords:
plastics (thermoplastic), plastic surgical devices/applications, polycarbonate (PC) plastics, polymers-surgical applications, resins-polycarbonate, seals, ICS Number Code 11.100.99 (Other standards related to laboratory medicine), 83.080.20 (Thermoplastic materials)
Doplňujúce informácie
| 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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