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
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...
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my-uthm-ep.64792022-02-06T21:04:36Z 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 2021-06 Azman, Naqibah R855-855.5 Medical technology T Technology (General) 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. 2021-06 Thesis http://eprints.uthm.edu.my/6479/ http://eprints.uthm.edu.my/6479/1/24p%20NAQIBAH%20AZMAN.pdf text en public http://eprints.uthm.edu.my/6479/2/NAQIBAH%20AZMAN%20COPYRIGHT%20DECLARATION.pdf text en staffonly http://eprints.uthm.edu.my/6479/3/NAQIBAH%20AZMAN%20WATERMARK.pdf text en validuser mphil masters Universiti Tun Hussein Onn Malaysia Fakulti Kejuruteraan Mekanikal dan Pembuatan |
| institution |
Universiti Tun Hussein Onn Malaysia |
| collection |
UTHM Institutional Repository |
| language |
English English English |
| topic |
R855-855.5 Medical technology T Technology (General) |
| spellingShingle |
R855-855.5 Medical technology T Technology (General) Azman, Naqibah 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 |
| description |
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. |
| format |
Thesis |
| qualification_name |
Master of Philosophy (M.Phil.) |
| qualification_level |
Master's degree |
| author |
Azman, Naqibah |
| author_facet |
Azman, Naqibah |
| author_sort |
Azman, Naqibah |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| granting_institution |
Universiti Tun Hussein Onn Malaysia |
| granting_department |
Fakulti Kejuruteraan Mekanikal dan Pembuatan |
| publishDate |
2021 |
| url |
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 |
| _version_ |
1747831069383589888 |