1.1 本规范涵盖了用于医疗植入物应用的原始形式（通常是颗粒、粉末或粒料）的丙烯酸树脂。共聚物仅限于无规共聚物。本规范规定了这种热塑性塑料在用于制造植入式医疗器械或植入式医疗器械组件时的要求和相关测试方法。 1.1.1 虽然可以使用各种共聚单体，但树脂的组成应包含聚甲基丙烯酸甲酯（PMMA）作为其主要成分。分类 D788 将丙烯酸模塑料定义为“至少70%的聚合物由甲基丙烯酸甲酯聚合而成。”本文使用的术语PMMA和丙烯酸通常是指如上所述的均聚物和共聚物。 1.2 与任何材料一样，某些特性可能会因生产特定零件或设备所需的加工技术（如成型、挤压、机加工、灭菌等）而改变。 因此，应使用供应商、买方和监管机构之间商定的适合确保安全性和有效性的测试方法来评估这种树脂的预制形式的性能。 1.3 本规范允许为所有医疗植入物应用指定丙烯酸树脂。医疗器械制造商和监管机构应评估特定应用的实际性能和适用性。 1.4 本规范中包含的性能适用于未填充的丙烯酸聚合物和含有硫酸钡的配制树脂。所示性能（表1和表X3.1）适用于未填充的注塑成型形式。本规范不包括含有除硫酸钡以外的填料、着色剂、含有PMMA的聚合物混合物或回收材料的模板。 1.5 遵守本规范并不排除对树脂制成的任何设备进行功能测试的需要，以证明其在预期应用中的有效性。 1.6 以国际单位制表示的值应被视为标准值。本标准不包括其他计量单位。 1.7 本标准并不旨在解决与其使用相关的所有安全问题（如果有的话）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。

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 implantable 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, health, and environmental 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.