Regulations Governing Management of Infectious Biological Materials Article 18
If a laboratory detects pathogens in Risk Groups 2-4 or biotoxins while conducting clinical or research testing or participating in proficiency testing, it shall, within the following time period, destroy, store, or transfer the detected pathogens or biotoxins to an entity that has obtained approval pursuant to Paragraph 2 or Paragraph 3 of Article 9 herein:1. Clinical or research testing: Within thirty days from the day following detection.2. Proficiency testing: Within ninety days from the day following detection.If the detected pathogens or biotoxins in the preceding paragraph are BSAT and have not been approved for possession, storage or use according to Paragraph 2 of the preceding article, the laboratory shall report the plan for their destruction, storage or transfer to the central competent authority for record within seven days from the day following detection, and then complete such handling within the time limit specified in the preceding paragraph.
中文原文 感染性生物材料管理辦法第18條
實驗室進行臨床、研究檢驗或參加能力試驗,其檢出之第二級至第四級危險群病原體、生物毒素,應於下列期限內,完成銷毀,或保存、移轉於已完成第九條第二項或第三項核定之設置單位:
一、臨床、研究檢驗:檢出之次日起三十日。
二、能力試驗:檢出之次日起九十日。
前項檢出之病原體、生物毒素為管制性生物材料,且非屬前條第二項經核准得持有、保存或使用者,實驗室應於檢出之次日起七日內,就其銷毀、保存或移轉,報中央主管機關備查後,依前項規定期限處理之。
一、臨床、研究檢驗:檢出之次日起三十日。
二、能力試驗:檢出之次日起九十日。
前項檢出之病原體、生物毒素為管制性生物材料,且非屬前條第二項經核准得持有、保存或使用者,實驗室應於檢出之次日起七日內,就其銷毀、保存或移轉,報中央主管機關備查後,依前項規定期限處理之。