【国外标准】 Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof. Physical and mechanical properties of medical grade polyoxymethylene such as specific gravity, water absorption, equilibrium, tensile yield strength, tensile elongation break, tensile modulus, tensile impact strength, compressive strength, and sheer strength shall be determined. Biocompatibility of acetal resins and implant devices made using these materials shall also be determined.1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components thereof.1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for a specific application. Therefore properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy.1.3 Although this resin has been used for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed.1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test levels, and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications.1.5 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 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.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.