Regulations Governing Management of Infectious Biological Materials Article 4
Pathogens in Risk Groups 2-4, biotoxins and positive specimens that may pose a severe hazard to public health and safety due to abuse or leakage shall be classified as biological select agents and toxins (hereafter referred to as “BSAT”).Laboratories and storage facilities that possess, store, use, or dispose of BSAT are classified as controlled premises.The directions for the subtypes, types, total quantity control, packaging, and other relevant matters governing BSAT, pathogens and biotoxins other than BSAT, as well as positive specimens, shall be prescribed by the central competent authority.
中文原文 感染性生物材料管理辦法第4條
第二級至第四級危險群病原體、生物毒素及陽性檢體，因遭濫用或洩漏，而對公共衛生及社會安全具有嚴重危害之虞者，為管制性生物材料。
實驗室、保存場所持有、保存、使用或處分管制性生物材料者，為管制作業場所。
管制性生物材料，及其他非管制性生物材料之病原體、生物毒素、陽性檢體，其細項、品類、管制總量、包裝及其他相關事項，由中央主管機關定之。
實驗室、保存場所持有、保存、使用或處分管制性生物材料者，為管制作業場所。
管制性生物材料，及其他非管制性生物材料之病原體、生物毒素、陽性檢體，其細項、品類、管制總量、包裝及其他相關事項，由中央主管機關定之。