Regulations Governing Management of Infectious Biological Materials Article 33
For positive specimens that are not yet inactivated and to which P620 packing instructions apply for their transport in accordance with the World Health Organization’s Guidance on Regulations for the Transport of Infectious Substances, the provisions governing pathogens in Risk Groups 3-4 under these Regulations shall apply to the management of their possession, storage, use, disposition, or import and export.The term “not yet inactivated” in the preceding paragraph means the positive specimen has not been treated with solvents, high temperatures, irradiation, or other effectively validated methods, such that it is still capable of causing human infection.For BSAT that are biotoxins whose quantity are below the control limits set forth by the central competent authority pursuant to Paragraph 3 of Article 4 herein, the provisions governing Risk Group 3 pathogens other than BSAT shall apply to their possession, storage, use, disposition, or import and export.
中文原文 感染性生物材料管理辦法第33條
陽性檢體未去活化,且依世界衛生組織所定感染性物質運輸指引,應適用P620運送包裝指示規範者,其持有、保存、使用、處分或輸出入之管理,比照本辦法有關第三級、第四級危險群病原體之規定辦理。
前項未去活化,指陽性檢體並未以溶劑、高溫、輻射或其他經有效驗證方法處理,仍具有造成人類感染之能力。
管制性生物材料屬未達中央主管機關依第四條第三項所定管制總量之生物毒素者,其持有、保存、使用、處分或輸出入之管理,比照非管制性生物材料之第三級危險群病原體規定辦理。
前項未去活化,指陽性檢體並未以溶劑、高溫、輻射或其他經有效驗證方法處理,仍具有造成人類感染之能力。
管制性生物材料屬未達中央主管機關依第四條第三項所定管制總量之生物毒素者,其持有、保存、使用、處分或輸出入之管理,比照非管制性生物材料之第三級危險群病原體規定辦理。