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Standard Specification for Square Drive Interconnections on Surgical Instruments 手术器械方形驱动互连标准规范
发布日期: 2018-10-01
1.1 本规范适用于手术期间用于医疗器械钻孔、攻丝、驱动或放置的手术器械的互连。 1.2 本规范包括驱动元件和从动元件的尺寸和公差。 1.3 ASME B107.4M-1995中给出的规范是为工业应用而设计的,对于外科应用而言过于宽松。用于工业应用的弹簧通常由碳钢制成,并且能够承受比不锈钢更高的负载。本标准中给出的规范旨在减少手术器械意外脱离的可能性。这种意外脱离可能会伤害患者或最终用户,或损坏或污染仪器。 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。 1.5 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 applies to interconnections of surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery. 1.2 This specification includes dimensions and tolerances for both driving and driven elements. 1.3 The specifications given in ASME B107.4M-1995 are designed for industrial applications and are considered too loose for surgical applications. Springs used for industrial applications are generally made from carbon steel and are capable of higher loads than their stainless steel counterparts. The specifications given in this standard have been written to lessen the chance of accidental disengagement of surgical instruments. This accidental disengagement could injure the patient or end user, or damage or contaminate the instrument. 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 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. 1.5 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: F04.33
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