Pre‐Registration Assessment of Bone‐Filling Products
| Autor: | Yue Min, Bin Liu, Bao Zhai, Xiao‐heng Guo, Jia‐yi Sun, Shuo Pan |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
China
Bone Regeneration Medical device Computer science Biosecurity Declaration 03 medical and health sciences 0302 clinical medicine Animal model lcsh:Orthopedic surgery Materials Testing Humans Orthopedics and Sports Medicine Experimental operations Pre-Registration 030222 orthopedics Bone Transplantation Instructional Courses Technical indices lcsh:RD701-811 Risk analysis (engineering) Research Design Bone Substitutes Surgery Bone‐filling material product 030217 neurology & neurosurgery |
| Zdroj: | Orthopaedic Surgery, Vol 11, Iss 5, Pp 720-724 (2019) Orthopaedic Surgery |
| ISSN: | 1757-7853 1757-7861 |
| Popis: | The use of bone-filling material to repair bone defects and fix implanted bone grafts is a developing area in medicine. Investigators can evaluate bone-filling materials through use of several indices to make comparisons and to determine suitability for application in humans1 . However, it is quite difficult to transform their discovery into practical use, because the viability of the studied material might require examination of all aspects of properties. In addition, for a material to become a product, a complete procedure involving a declaration, registration, and approval is necessary. This article introduces the technical indices that the investigators and reporters should provide in their declaration and registration data to meet the relevant standards in China. The indices include physical and chemical properties, biocompatibility, biosecurity, pre-clinical animal model tests, sterilization and disinfection, product duration, and packaging. Full consideration of all possible indices is crucial to realize the transformation from a designed product to a commercial medical device, which requires effective interaction between clinicians and engineers. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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