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Description of ASTM-F665 2009ASTM F665 - 09Standard Classification for Vinyl Chloride Plastics Used in Biomedical ApplicationActive Standard ASTM F665 | Developed by Subcommittee: F04.11 Book of Standards Volume: 13.01 ASTM F665Significance and Use
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. 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 1For 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. ASTM Standards D149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies D150 Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation D257 Test Methods for DC Resistance or Conductance of Insulating Materials D543 Practices for Evaluating the Resistance of Plastics to Chemical Reagents D570 Test Method for Water Absorption of Plastics D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement D882 Test Method for Tensile Properties of Thin Plastic Sheeting D955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics D2124 Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique D2240 Test Method for Rubber Property--Durometer Hardness F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices ISO Standard ISO10993 Biological Evaluation of Medical Devices Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.Keywords plastic surgical devices/application; vinyl chloride plastics; Classification (standards)--medical/surgical applications; Plastic surgical devices/applications; Vinyl chloride polymers; ICS Code ICS Number Code 07.100.10 (Medical microbiology); 11.040.40 (Implants for surgery, prothetics and orthotics) DOI: 10.1520/F0665-09 ASTM International is a member of CrossRef. ASTM F665This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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