GSO ASTM F3087:2021

Standard Specification for Acrylic Molding Resins for Medical Implant Applications


 

 

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标准号
GSO ASTM F3087:2021
发布
2021年
发布单位
GSO
当前最新
GSO ASTM F3087:2021
 
 
适用范围
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.

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