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Significance and Use
This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.
The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.
1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.
1.2 The tests and methods listed in this guide may be referenced in specification containing minimum required values and tolerances for specific end-use products.
1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.
1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.
1.5 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
D395 Test Methods for Rubber Property--Compression Set
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension
D570 Test Method for Water Absorption of Plastics
D575 Test Methods for Rubber Properties in Compression
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1242 Test Methods for Resistance of Plastic Materials to Abrasion
D1434 Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
D1544 Test Method for Color of Transparent Liquids (Gardner Color Scale)
D1638 Methods of Testing Urethane Foam Isocyanate Raw Materials
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
D2857 Practice for Dilute Solution Viscosity of Polymers
D2990 Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3137 Test Method for Rubber Property--Hydrolytic Stability
D3418 Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
E96/E96M Test Methods for Water Vapor Transmission of Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and 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 11.120.01 (Pharmaceutics in general); 83.080.20 (Thermoplastic materials)
UNSPSC Code 13102029(Rigid Thermoplastic Polyurethane RPTU); 85131703(Biomedical research services)