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Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants 医疗器械和外科植入物用变形镍钛形状记忆合金的标准规范
发布日期: 2018-08-01
1.1 本规范涵盖了锻制镍钛棒、扁轧产品和标称镍含量为54.5%至57.0%且用于制造医疗器械和外科植入物的管子的化学、物理、机械和冶金要求。 1.2 要求适用于尺寸为5.50至94.0 mm[0.218至3.70 in]的磨机产品在直径或厚度上。研磨产品不具有医疗器械、植入物或其组件的最终形状、最终表面光洁度或最终特性。 成品镍钛冷加工管应按规范考虑 F2633 . 1.3 以国际单位制或英寸-磅单位表示的数值应单独视为标准值。每个系统中规定的值可能不是精确的等效值;因此,每个系统应相互独立使用。将两个系统的值合并可能会导致不符合标准。 1.4 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 the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants. 1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633 . 1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard. 1.4 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: F04.12
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