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Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants (UNS R30003, UNS R30008, UNS R30035, UNS R30605, and UNS R31537) 外科植入物用锻造无缝、焊接和拉制钴合金小直径管的标准规范
发布日期: 2024-01-01
1.1 本规范涵盖了用于制造外科植入物的锻造无缝、焊接和拉伸钴合金小直径管的要求。材料应符合规范的适用要求 F90 , F562 , F688 , F1058 或 F1537 ,合金1。本规范涉及将小直径医用管道与本规范中涵盖的棒材、线材、片材和带材产品形式区分开来的产品变量。 1.2 本规范适用于公称外径(OD)小于6.3 mm[0.250 in.]和0.76 mm[0。 030英寸]和较薄的标称壁厚。 1.3 中的规范 2.1 在本规范中称为ASTM材料标准。 1.4 以国际单位制或英寸磅单位表示的数值应单独视为标准。每个系统中规定的值不一定是完全相等的;因此,为了确保符合标准,每个系统应独立使用,并且不得将两个系统的值组合使用。 1.5 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。 1.6 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 the requirements for wrought seamless and welded and drawn cobalt alloy small diameter tubing used for the manufacture of surgical implants. Material shall conform to the applicable requirements of Specifications F90 , F562 , F688 , F1058 or F1537 , Alloy 1. This specification addresses those product variables that differentiate small diameter medical tubing from the bar, wire, sheet, and strip product forms covered in these specifications. 1.2 This specification applies to straight length tubing with 6.3 mm [0.250 in.] and smaller nominal outside diameter (OD) and 0.76 mm [0.030 in.] and thinner nominal wall thickness. 1.3 The specifications in 2.1 are referred to as the ASTM material standard(s) in this specification. 1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined. 1.5 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. 1.6 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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