Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
用于制造医疗器械的不锈钢针管 - 要求和测试方法
发布日期:
2016-08-02
ISO 9626:2016适用于刚性不锈钢针管,适用于制造皮下注射针和其他主要供人类使用的医疗设备。
它提供了医疗设备中使用的针头组件所用管的要求和测试方法。当组件被纳入现成设备中时,可能需要对管道方面进行额外的性能测试。
它规定了指定公制尺寸为3.4mm(10规)至0.18mm(34规)的钢管的尺寸和机械性能。
它不适用于柔性不锈钢管,因为机械性能与ISO 9626中规定的刚性管不同:
2016年。但是,鼓励挠性管制造商和购买者采用ISO 9626:2016中给出的尺寸规范。
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.