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Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
Automatische name übersetzung:
Standardklassifikation für Vinylchlorid Plastics in Biomedical Anwendung für
NORM herausgegeben am 1.3.2015
Bezeichnung normen: ASTM F665-09(2015)
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.3.2015
SKU: NS-587591
Zahl der Seiten: 4
Gewicht ca.: 12 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Medical microbiologyImplants for surgery, prosthetics and orthotics
Keywords:
plastic surgical devices/application, vinyl chloride plastics ,, ICS Number Code 07.100.10 (Medical microbiology),11.040.40 (Implants for surgery, prothetics and orthotics)
Significance and Use | ||||||||||||||||||||||||||
4.1 This classification was developed to permit the addition of descriptive symbols and values for further new formulations with improved properties without complete reorganization of the standard and to facilitate the incorporation of future new test methods to keep pace with changing industry requirements. |
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1. Scope | ||||||||||||||||||||||||||
1.1 This classification provides guidance to engineers and users in the selection of practical vinyl chloride plastics for medical applications and further provides a method for specifying these materials by use of a simple line call-out designation. This classification excludes vinyl chloride plastics used in long-term implants. 1.2 Use is made of a classification scheme based on the premise that the composition of vinyl chloride plastics, copolymers, fillers, plasticizers, stabilizers, and other additives in these systems can be arranged into characteristic material designations. 1.3 In all cases where the provisions of this classification system would conflict with those of the detailed specification for a particular device, the latter shall take precedence. Note 1: For cases in which the vinyl chloride plastic may be
used for purposes where the requirements are too specific to be
completely described by this classification system, it is advisable
for the purchaser to consult the supplier to secure adjustment of
the properties to suit the actual conditions to which the device is
to be subjected.
1.4 The biocompatibility of vinyl chloride plastics as a class of materials has not been established. Since many compositions and formulations fall under this class, it is essential that the fabricators/device manufacturers assure the safety and efficacy of the specific composition or formulation, in its intended application, using state-of-the-art test methods. 1.5 This classification is to assist the interface between the material supplier and the device manufacturer (fabricator) who purchases a formulated vinyl chloride plastic for a component. For those device manufacturers (fabricators) who do their own formulating, compounding, extrusion, molding, and so forth, this classification does not apply. 1.6 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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Historisch
1.3.2013
Historisch
1.11.2012
Historisch
1.3.2011
Historisch
1.12.2014
Historisch
1.3.2011
Historisch
1.9.2013
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