The thesis explores the concurrent development of a medical endoscope sterilizer and its compliance with IEC 61010. Unlike the traditional sequential approach, we applied concurrent engineering to optimize temperature regulation. A temperature controller was developed alongside software code, an electrical schematic, and a circuit for precise chamber temperature control. Testing confirmed compliance with ISO 15883 and successful completion of all IEC 61010 safety evaluations. By integrating verification early in the process, we reduced development time and minimized potential redesigns, fixes and/or adjustments. The use of concurrent engineering allowed simultaneous hardware and software validation, ensuring functional reliability and regulatory conformity. The findings demonstrate that real-time compliance assessment during development significantly accelerates certification while maintaining high apparatus safety and performance standards. This approach proves effective for optimizing complex medical apparatusses with precise controls and stringent regulatory compliance.
|
