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O. Bodur, G. Poszvek, E. Walcher, M.N. Durakbasa, J.M. Bauer:
"Intelligent Design and Advanced Precision Metrology on the Geometrical Structure of Medical Needles Based on GPS and ISO Standards";
in: "Digital Conversion on the Way to Industry 4.0 - Lecture Notes in Mechanical Engineering", 1; M.N. Durakbasa, G. Gencyilmaz (ed.); issued by: Springer Nature Switzerland AG; Springer Nature Switzerland AG, Cham, Switzerland, 2020, ISSN: 2195-4364, 346 - 362.

Medical products generally occupy a significant place in advanced
manufacturing technology. Due to their sophisticated production systems, these productions are looking for high-precision measurement technology on a microscale within the high-quality functional requirements. Sophisticated metrology, as an important part of the production system in the context of Industry 4.0 reduces the uncertainties of measurement processes in the geometry of the manufactured parts and contributes to the preparation of critical solutions for high product and process quality through established standards and integrated management systems. In the context of Industry 4.0, manufacturing systems are updated to an intelligent level. The medical products shall design intelligently according to the functional requirements, and geometrical tolerances and form deviations adjusted the functional characteristics in production performance specifications. However, there is some deficiency of research on the form and geometrical tolerances, even if there are several articles that give information on the mathematical model of needle geometry. The purpose of this research is to indicate an advanced approach with precise measurement methods and intelligent measuring instruments in the production of medical devices to integrate the specifications of precision metrology and to encounter the sustained improvements towards more accurate geometrical structures in the manufacturing of workpieces. Considering this context, the congruent angles of the needles are specified, which affect the functional specifications of the medical needles. The form deviation and geometrical tolerances of the medical needle are implemented on the 2D and 3D technical drawings depending on the associated applicable GPS system and ISO standards. Besides, the surface structures of the medical needles are observed by using advanced metrology techniques through a digital microscope. Accordingly, the surface and multi-line roughness parameters of each surface formed in manufacturing steps by a ground operation, are evaluated.

Advanced metrology Medical needle Hypodermic GPS Form deviation Surface roughness Gauge Pre-fillable syringes BPMN

http://dx.doi.org/10.1007/978-3-030-62784-3_29