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Significance 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.
1.1 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 StandardISO10993 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.
ICS Number Code 07.100.10 (Medical microbiology); 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42295500(Surgical implants and expanders and extenders and surgical wires and related products)