Establishment of checklist of design for safety (DfS), life cycle analysis (LCA) and design for manufacturing (DFM) for ivd medical device based on IEC 60601

• Main Author: Azman, Naqibah
• Format: Thesis
• Language: English; English; English
• Published: 2021
• Subjects: R855-855.5 Medical technology; T Technology (General)
• Online Access: http://eprints.uthm.edu.my/6479/1/24p%20NAQIBAH%20AZMAN.pdf; http://eprints.uthm.edu.my/6479/2/NAQIBAH%20AZMAN%20COPYRIGHT%20DECLARATION.pdf; http://eprints.uthm.edu.my/6479/3/NAQIBAH%20AZMAN%20WATERMARK.pdf; http://eprints.uthm.edu.my/6479/
• Institution: Universiti Tun Hussein Onn Malaysia

By 2030, medical industries is projected to grow exponentially, progressive to more sustainable policies and better performance towards achieving healthcare Sustainable Development Goals (SDGs). Designing the uprising star of In-Vitro Diagnostic (IVD) device casing is choose as a case study in this research because the current discovery of non-invasive jaundice meter in Malaysia are still in lab scale form with wooding casing thus made it not user friendly and not safe to be used. Therefore, this research purpose a comprehensive checklist for designing new medical device casing by considering Design for Safety (DfS) extracted from the famous international standards on safety MS IEC 60601 and Life-Cycle Assessment (LCA) principles for environmental impact with real side-by-side industrial manufacturing requirement for injection molding process applied on a case study of jaundice meter casing. The checklist have help to minimize modification period thus comply to safety standards (MS IEC 60601). As a result, DfS-LCA-DFM comprehensive checklist helps to decrease trouble for designers to read on long pages of regulatory book to comply to safety standards, doing forensic of redesigning due to not suitable design for manufacturing and saving cost of raw material during early design stage.