Regulations Governing Management of Infectious Biological Materials Article 29
The biosafety incidents occurring at a laboratory or storage facility are classified into the following hazard levels by the extent of infectious biological material leakage or the status of personnel infection:1. High:(1) A biosafety incident involving personnel at the laboratory or storage facility that leads to the infection of personnel; or(2) Leakage of infectious biological materials beyond the laboratory or storage facility that poses a risk of infection or harm to persons outside the laboratory or storage facility.2. Moderate:(1) A biosafety incident at the laboratory or storage facility that poses a risk of infection or harm to personnel; or(2) Leakage of infectious biological materials confined to areas within the laboratory or storage facility that poses a risk of infection or harm to personnel.3. Low: Leakage of infectious biological materials confined to the safety equipment within the laboratory or storage facility that poses a risk of infection or harm to personnel.When an incident in the preceding paragraph has occurred or is likely to occur, the laboratory or storage facility shall inform the BSO immediately, and the controlled premises shall inform the BSAT officer immediately. The laboratory, storage facility, or controlled premises shall also take necessary response measures according to the established emergency response procedures and emergency response plan.The directions for the reporting and management of incidents mentioned in the preceding two paragraphs shall be prescribed by the central competent authority.
中文原文 感染性生物材料管理辦法第29條
實驗室、保存場所發生之生物安全事故，依感染性生物材料洩漏程度或人員感染情形，分為下列危害等級：
一、高度：
（一）實驗室、保存場所工作人員發生生物安全事故致感染。
（二）感染性生物材料洩漏至實驗室、保存場所以外區域，致有感染或危害實驗室、保存場所以外人員之虞。
二、中度：
（一）實驗室、保存場所工作人員發生生物安全事故，致有感染或危害工作人員之虞。
（二）感染性生物材料洩漏局限於實驗室、保存場所以內區域，致有感染或危害工作人員之虞。
三、低度：感染性生物材料洩漏局限於實驗室、保存場所之安全設備內，致有感染或危害工作人員之虞。
前項事故發生或有發生之虞時，實驗室、保存場所應立即通報生安主管，其為管制作業場所者，應立即通報管制性生物材料主管；並依緊急應變處理流程、緊急應變計畫，採取必要之應變措施。
前二項事故之通報細節及處理措施，由中央主管機關定之。
一、高度：
（一）實驗室、保存場所工作人員發生生物安全事故致感染。
（二）感染性生物材料洩漏至實驗室、保存場所以外區域，致有感染或危害實驗室、保存場所以外人員之虞。
二、中度：
（一）實驗室、保存場所工作人員發生生物安全事故，致有感染或危害工作人員之虞。
（二）感染性生物材料洩漏局限於實驗室、保存場所以內區域，致有感染或危害工作人員之虞。
三、低度：感染性生物材料洩漏局限於實驗室、保存場所之安全設備內，致有感染或危害工作人員之虞。
前項事故發生或有發生之虞時，實驗室、保存場所應立即通報生安主管，其為管制作業場所者，應立即通報管制性生物材料主管；並依緊急應變處理流程、緊急應變計畫，採取必要之應變措施。
前二項事故之通報細節及處理措施，由中央主管機關定之。