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Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications 外科植入物用金属注射成型非合金钛部件的标准规范
发布日期: 2021-11-01
1.1 本规范涵盖了用于制造外科植入物的两种类型的三级金属注射成型(MIM)非合金钛组件的化学、机械和冶金要求。 1.2 本规范涵盖的1类MIM部件可能已通过烧结后处理密度超过其烧结密度。 1.3 英寸-磅或国际单位制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。合并两个系统的值可能会导致不符合规范。 1.4 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。 1.5 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, mechanical, and metallurgical requirements for three grades of metal injection molded (MIM) unalloyed titanium components in two types to be used in the manufacture of surgical implants. 1.2 The Type 1 MIM components covered by this specification may have been densified beyond their as-sintered density by post-sinter processing. 1.3 Values in either inch-pound or SI are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independent of the other. Combining values from the two systems may result in nonconformance with the specification. 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.
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归口单位: F04.12
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