Regulations Governing Management of Infectious Biological Materials Article 2
The terms used in these Regulations are defined as follows:1. “Infectious biological materials” refers to infectious pathogens or derivatives thereof mentioned in Paragraph 4, Article 4 of the Act, and substances confirmed to contain such pathogens or derivatives.2. “Entity” refers to an organization, institution, school, legal person or group that possesses, stores, uses, disposes of, or imports and exports infectious biological materials and has set up a laboratory or storage facility therefor.3. “Laboratory” refers to a facility that uses infectious biological materials to conduct experimental operations for testing or research purposes.4. “Storage facility” refers to a facility that stores or disposes of infectious biological materials.5. “Biosafety” refers to safeguard measures implemented to protect personnel from accidental exposure to or prevent leakage of infectious biological materials.6. “Biosecurity” refers to protective and management measures implemented to prevent unauthorized access, loss, theft, abuse, transfer or leakage of infectious biological materials.7. “Disposition” refers to the act of adding or removing infectious biological materials, or increasing or decreasing their quantities.8. “Transfer” refers to the act of a sender transferring infectious biological materials possessed or stored by it to a recipient.9. “Pathogen” refers to infectious pathogenic microorganisms and their cultures (culture media) that can cause infections in humans.10. “Biotoxin” refers to purified and/or isolated toxic substances produced by pathogens.11. “Derivatives” refers to the purified or isolated components of pathogens, including nucleic acids, plasmids, proteins, other components, and biotoxins.12. “Positive specimen” refers to a human specimen collected from an infectious disease patient who is not yet cured, or a human specimen that has been tested and confirmed to contain pathogens.13. “Incident” refers to an irregular event involving infectious biological materials or occurring in a laboratory or storage facility that poses the risk of infecting or endangering personnel.
中文原文 感染性生物材料管理辦法第2條
本辦法用詞，定義如下：
一、感染性生物材料：指本法第四條第四項所定具感染性之病原體或其衍生物，及經確認含有此等病原體或衍生物之物質。
二、設置單位：指持有、保存、使用、處分或輸出入感染性生物材料，並設有實驗室或保存場所之機關、機構、學校、法人或團體。
三、實驗室：指為檢驗或研究目的，使用感染性生物材料進行實驗操作之場所。
四、保存場所：指保存、處分感染性生物材料之場所。
五、生物安全：指為預防工作人員意外暴露，或預防洩漏感染性生物材料，而實施之防護措施。
六、生物保全：指為防止感染性生物材料未經授權而取得、遺失、遭竊、濫用、移轉或洩漏，所實施之保護及管理措施。
七、處分：指感染性生物材料之新增、刪除品項或增減數量之行為。
八、移轉：指提供單位將持有、保存之感染性生物材料，轉予接收單位之行為。
九、病原體：指具感染性，且可造成人類感染之病原微生物及其培養物（液）。
十、生物毒素：指病原體產出，且經純化、分離之有毒物質。
十一、衍生物：指病原體經純化、分離之核酸、質體、蛋白質或其他組成成分，及生物毒素。
十二、陽性檢體：指採自未治癒之感染性疾病病人，或經檢驗確認含有病原體之人類檢體。
十三、事故：指涉及感染性生物材料或發生於實驗室、保存場所之異常事件，致有感染或危害工作人員之虞。
一、感染性生物材料：指本法第四條第四項所定具感染性之病原體或其衍生物，及經確認含有此等病原體或衍生物之物質。
二、設置單位：指持有、保存、使用、處分或輸出入感染性生物材料，並設有實驗室或保存場所之機關、機構、學校、法人或團體。
三、實驗室：指為檢驗或研究目的，使用感染性生物材料進行實驗操作之場所。
四、保存場所：指保存、處分感染性生物材料之場所。
五、生物安全：指為預防工作人員意外暴露，或預防洩漏感染性生物材料，而實施之防護措施。
六、生物保全：指為防止感染性生物材料未經授權而取得、遺失、遭竊、濫用、移轉或洩漏，所實施之保護及管理措施。
七、處分：指感染性生物材料之新增、刪除品項或增減數量之行為。
八、移轉：指提供單位將持有、保存之感染性生物材料，轉予接收單位之行為。
九、病原體：指具感染性，且可造成人類感染之病原微生物及其培養物（液）。
十、生物毒素：指病原體產出，且經純化、分離之有毒物質。
十一、衍生物：指病原體經純化、分離之核酸、質體、蛋白質或其他組成成分，及生物毒素。
十二、陽性檢體：指採自未治癒之感染性疾病病人，或經檢驗確認含有病原體之人類檢體。
十三、事故：指涉及感染性生物材料或發生於實驗室、保存場所之異常事件，致有感染或危害工作人員之虞。