Luer Measurement Solutions

 Luer connector: A standardized micro-volume, non-permeable connector used for medical devices for intravascular or subcutaneous applications, such as syringes, IV infusion sets, IV catheters, drug mixing adapters, positioning mechanisms for interventional medical devices (such as balloon), etc. Substandard Luer connectors or incorrect connections can allow inappropriate medications, liquid nutritional formulas, or air to enter, causing serious or even fatal injury to the patient. In response to the above problems, the latest international standard (ISO 80369) of "Small Hole Connectors for Medical Liquids and Gases" puts forward new requirements for the size measurement of Luer connectors.

Measurement Requirements and Difficulties Faced According to ISO 80369

 ISO 80369 clearly stipulates the size specifications of Luer connectors, and one of the key dimensions is the No. 1 complete thread profile. The current manufacturing method for the internal luer thread is to use a core in the mold. Since the angular orientation of the core does not constrain the angular orientation of the entire part, there is a high probability that the section of any thread profile will not point to the No. 1 full thread profile. In addition, other important thread features are randomly distributed in the Z direction, which is difficult to measure using conventional measuring tools or instruments.

- Using 2D sections, it is very easy to derive all dimensions specified by the ISO 80369 standard;

- All dimensions of the male luer are displayed in the 3D view:

 The United States has required the production of Luer connectors in accordance with the ISO 80369 standard since 2018; from January 1, 2020, the FDA will no longer accept new product applications for Luer connectors based on the old standard. At present, my country has transformed the two general standards in ISO 80369, and YY/T 0916.7 (corresponding to ISO 80369-7) for luer connectors has also entered the stage of soliciting opinions. The implementation of the new standard will have a huge impact on the medical device industry. In terms of measurement, medical device manufacturers also need to use new technologies and master new methods to maintain market competitiveness in the new round of competition.