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Standard Specification for Acrylic Bone Cement 丙烯酸骨水泥标准规范
发布日期: 2021-03-15
1.1 本规范涵盖主要用于骨科内假体固定的自固化树脂。根据制造商的建议,混合物可用于面团前或面团阶段。 1.2 预先测量的粉末和液体单位以适合混合的形式提供。然后混合物凝固。 1.3 虽然可以加入多种共聚物和共聚单体,但凝结水泥的成分应包含聚(甲基丙烯酸酯)作为其主要成分。 1.4 本规范涵盖成分、物理性能、生物相容性以及包装要求。文献中报道了传统配方和使用的丙烯酸骨水泥的生物相容性 ( 1. , 2. ) . 2. 1.5 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.6 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)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》中确立的国际公认标准化原则制定的。
1.1 This specification covers self-curing resins used primarily for the fixation of internal orthopedic prostheses. The mixture may be used in either the pre-dough or dough stage in accordance with the manufacturer’s recommendations. 1.2 Units of pre-measured powder and liquid are supplied in a form suitable for mixing. The mixture then sets in place. 1.3 While a variety of copolymers and comonomers may be incorporated, the composition of the set cement shall contain poly(methacrylic acid esters) as its main ingredient. 1.4 This specification covers compositional, physical performance, and biocompatibility as well as packaging requirements. The biocompatibility of acrylic bone cement as it has been traditionally formulated and used has been reported in the literature ( 1 , 2 ) . 2 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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.
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归口单位: F04.11
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