頁籤選單縮合
題 名 | A CNLA Certified Testing Laboratory for Electrical Medical Apparatus |
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作 者 | Lin, Chii-wann; Chen, Po-quang; Chen, Chin-te; Lu, Chung-ming; Chien, Jia-hung; Yang, Chiu-hung; Huang, Chun-kai; Wang, Cheng-yi; Tseng, Yung-zu; Liu, Hwa-chang; | 書刊名 | 醫學工程 |
卷 期 | 12:5 民89.10 |
頁 次 | 頁230-233 |
分類號 | 410.025 |
關鍵詞 | Electrical safety; Testing; Standards; |
語 文 | 英文(English) |
英文摘要 | The establishment of a certified ISO Guide 25 testing laboratory for medical devices is an important corner stone for a better national medical device management system and practices of the assorted standards or guidelines. It can also contribute significantly to the educational program for clinical engineer. As a starting point, a medical electrical safety-testing laboratory according to the AAMI ES-1 (1993) and IEC 60601 (1988) has been setup and devoted to the safety of electrometrical apparatus with joined efforts of the Institute of Biomedical Engineering, National Taiwan University and Department of Biomedical Engineering, National Taiwan University Hospital. To ensure its quality of services, ISO/IEC Guide 25 is implemented and certified by Chinese National Laboratory Accreditation (CNLA). In view of the global harmonization, this painstaking procedure for a medical device regulation and development. In this paper, we will discuss the necessary procedures to train a clinical engineer to account for this need. |
本系統中英文摘要資訊取自各篇刊載內容。