頁籤選單縮合
題 名 | 我國感染性生物材料管理之變革與展望=Changes and Prospects of Infectious Biological Materials Management in Taiwan |
---|---|
作 者 | 吳文超; 蔡威士; 曾淑慧; | 書刊名 | 疫情報導 |
卷 期 | 30:21 2014.11.11[民103.11.11] |
頁 次 | 頁434-439 |
分類號 | 419.38 |
關鍵詞 | 感染性生物材料; 實驗室生物安全; 危險群微生物; 生物安全會; 生物風險管理; Infectious biological materials; Laboratory biosafety; Risk group; Biosafety committee; Biorisk management; |
語 文 | 中文(Chinese) |
中文摘要 | 「感染性生物材料管理辦法」於 2014年 3月 11日公告,使得我國實驗室生物安全管理法規更周延及完備。與先前「感染性生物材料管理及傳染病病人檢體採檢辦法」之差別,除將傳染病病人檢體採檢相關管理規定刪除外,主要修正重點包括:(一)界定感染性生物材料關聯之實體組織;(二)以第二級以上危險群微生物及生物毒素等感染性生物材料為管理重點;(三)明訂生物安全會組成人員及生物安全會專責人員資格;(四)修正生物安全第二等級實驗室之安全設備要求;(五)建立第二級以上危險群微生物及生物毒素等感染性生物材料之異常通報機制;(六)訂定感染性生物材料運送之三層包裝規定;(七)賦與地方衛生主管機關之生物安全管理權責;(八)修訂實驗室人員醫學監測及教育訓練規定。為使我國實驗室生物安全管理符合國際趨勢,將遵循世界衛生組織於 2012年公布「2012年至 2016年實驗室生物風險管理策略框架行動」之文件,逐步推動我國實驗室導入生物風險管理系統之政策,落實設置單位及其生物安全會自主管理能力,保障我國實驗室工作人員之安全無虞。 |
英文摘要 | The "Regulations Governing Management of Infectious Biological Materials" was announced on March 11, 2014. It makes laboratory biosafety regulations more appropriate and complete. In addition to deleting the relevant regulations on infectious patient specimen collection from the previous "Regulations Governing Management of Infectious Biological Materials and Collection of Specimens from Patients of Communicable Diseases", the major amendments include: (1) defining organizational entity which relates to infectious biological materials; (2) the management of infectious biological materials focuses on the risk group 2 and above microorganisms and biological toxins; (3) clarifying the qualifications of the biosafety committee and the biosafety staff; (4) amending the safety equipment requirements of biosafety level 2 laboratory; (5) the establishment of reporting mechanism of the risk group 2 and above microorganisms and biological toxins; (6) setting triple packaging rules regarding infectious biological material transport packaging requirements; (7) offering the safety management responsibilities to local health authorities; (8) amending the medical monitoring and education/training requirements of laboratory personnel. To ensure that laboratory biosafety management in Taiwan fit into international trends, the "Laboratory Biorisk Management Strategic Framework for Action 2012-2016" released by World Health Organization in 2012 is followed, and shall gradually promote the policy of laboratory biorisk management system, set capability of the installation units to implement self-management and biosafety committee, ensure safety works of the laboratory staff in Taiwan. |
本系統中英文摘要資訊取自各篇刊載內容。