标准摘要
[中文适用范围]： 本标准适用于用于制造人用注射用针头及其他医疗器械的刚性不锈钢针管。本标准提供了用于制造作为医疗器械组件的针头的管材的要求和试验方法。当该组件被集成在成品医疗器械中时，可能需要对管材方面进行额外的性能测试。本标准规定了设计尺寸为3.4 mm（10号规）至0.18 mm（34号规）的管材的尺寸和机械性能。本标准不适用于柔性不锈钢管，因为其机械性能与本标准规定的刚性管材不同。但是，鼓励柔性管材的制造商和采购者采用本标准中给出的尺寸规格。 [外文原描述]： 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. It 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. It 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 ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.
英文名称Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods