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现行 ASTM F639-09(2024)
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Standard Specification for Polyethylene Plastics for Medical Applications 医用聚乙烯塑料标准规范
发布日期: 2024-05-01
1.1 本规范涵盖聚乙烯塑料(定义见术语 D883 )用于涉及人体组织接触装置、30天或更短时间的短期留置和流体转移装置的医疗装置应用。这些材料作为一类的生物相容性尚未确定。必须对最终产品进行生物相容性测试。 1.2 本规范不适用于超高分子量聚乙烯(UHMWPE)塑料,例如用于关节植入物等的塑料。 1.3 以国际单位制表示的数值应视为标准。 本标准不包括其他计量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者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。 1.5 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。 ====意义和用途====== X1.2 意义 X1.2.1 微量金属的浓度是作为模拟体液中的提取物来测量的。提取物中的金属浓度基于提取的塑料的表面积,从该表面积可以估计可输送给患者的金属总量。
1.1 This specification covers polyethylene plastics (as defined in Terminology D883 ) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product. 1.2 This specification is not applicable to ultra-high molecular weight polyethylene (UHMWPE) plastics, such as those used in joint implants, and so forth. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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. ====== Significance And Use ====== X1.2 Significance X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.
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发布单位或类别: 美国-美国材料与试验协会
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归口单位: F04.11
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