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现行 BS EN ISO 9626:2016
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Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods 医疗器械制造用不锈钢针管 要求和试验方法
发布日期: 2016-09-30
BS EN ISO 9626:2016适用于适用于管道系统的刚性不锈钢针管 主要供人类使用的皮下注射针和其他医疗设备的制造。 本国际标准规定了制造的管道的要求和试验方法 针头作为医疗设备中使用的部件。可能需要对管道方面进行额外的性能测试 当该组件被纳入随时可用的设备中时,需要使用该组件。本国际标准规定了钢管的尺寸和机械性能 指定公制尺寸为3.4毫米(10号)至0.18毫米(34号)。它不适用于柔性不锈钢管,因为其机械性能与柔性不锈钢管不同 本国际标准中规定了刚性管。然而,制造商和购买者 鼓励挠性管制造商采用本国际标准中给出的尺寸规格 标准交叉引用:ISO 3696ISO 15510ISO 14971ISO 10993-1ISO/TR 19244购买本文件时提供的所有当前修订版均包含在购买本文件中。
BS EN ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This International Standard provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.This International Standard specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.Cross References:ISO 3696ISO 15510ISO 14971ISO 10993-1ISO/TR 19244All current amendments available at time of purchase are included with the purchase of this document.
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发布单位或类别: 英国-英国标准学会
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