【国外标准】 Standard Specification for Acrylic Molding Resins for Medical Implant Applications

This specification covers requirements and corresponding test methods for acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers, which shall contain poly(methyl methacrylate) (PMMA) as the primary ingredient and are intended for use in manufacturing implantable medical devices or components of medical devices. They shall undergo appropriate testing to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.This specification includes chemical and mechanical properties that are applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. It also covers sampling, appearance, certification, and assessment of selected tissue effects of implant devices made using acrylic polymers.1.1 This specification covers acrylic resins supplied in virgin form (typically pellets, powder, or granules) for medical implant applications. The co-polymers are limited to random co-polymers. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing implantable medical devices or components of medical devices.1.1.1 While a variety of co-monomers may be used, the composition of the resin shall contain poly(methyl methacrylate) (PMMA) as its primary ingredient. Classification D788 defines an acrylic molding compound as “having at least 70% of the polymer polymerized from methyl methacrylate.” The terms PMMA and acrylic as used herein refer generically to both the homopolymer and to co-polymers as defined above.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 the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods that are appropriate to ensure safety and efficacy as agreed upon between the supplier, purchaser, and regulating bodies.1.3 This specification allows for designation of acrylic resins for all medical implant applications. The actual extent of performance and suitability for a specific application shall be evaluated by the medical device manufacturer and regulating bodies.1.4 The properties included in this specification are those applicable for both unfilled acrylic polymers and for formulated resins containing barium sulfate. Indicated properties (Table 1 and Table X3.1) are for unfilled injection molded forms. Forms containing fillers other than barium sulfate, colorants, polymer blends that contain PMMA, or reclaimed materials are not covered by this specification.1.5 Compliance with this specification does not obviate the need for functional testing of any device fabricated from the resin to demonstrate effectiveness in its intended application.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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.