Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
|Publication Date:||10 August 1998|
|ICS Code (Thermoplastic materials):||83.080.20|
|ICS Code (Surgical instruments and materials):||11.040.30|
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 there of.
1.2 As will any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, etc.) 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 and 510(k) cleared by the U.S. Food and Drug Administration for specific implant applications, 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 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.