【国外标准】 Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application

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.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.