Wir benötigen Ihre Einwilligung zur Verwendung der einzelnen Daten, damit Sie unter anderem Informationen zu Ihren Interessen einsehen können. Klicken Sie auf "OK", um Ihre Zustimmung zu erteilen.
Standard Specification for Acrylic Molding Resins for Medical Implant Applications (Withdrawn 2024)
Automatische name übersetzung:
Standard-Spezifikation für Acrylformharzefür medizinische Implantatanwendungen
NORM herausgegeben am 15.7.2015
Bezeichnung normen: ASTM F3087-15
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 15.7.2015
SKU: NS-612386
Zahl der Seiten: 5
Gewicht ca.: 15 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Keywords:
acrylic resins, co-polymers, molding, PMMA, polymers, surgical applications,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
1. Scope | ||||||||||||||||||||
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. |
||||||||||||||||||||
2. Referenced Documents | ||||||||||||||||||||
|
Bereitstellung von aktuellen Informationen über legislative Vorschriften in der Sammlung der Gesetze bis zum Jahr 1945.
Aktualisierung 2x pro Monat!
Brauchen Sie mehr Informationen? Sehen Sie sich diese Seite an.
Letzte Aktualisierung: 2024-09-02 (Zahl der Positionen: 2 345 509)
© Copyright 2024 NORMSERVIS s.r.o.