Fed Regist. 2006 Dec 19;71(243):75865-79.
The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).
美国食品药品监督管理局（FDA）正在发布一项最终规则，以提高在美国销售的医用手套的阻隔质量。该规则将通过降低FDA对医用手套进行测试时发现的泄漏和视觉缺陷的现行可接受质量水平（AQL）来实现这一目标。通过降低医用手套的AQL，FDA还将使其AQL与国际标准化组织（ISO）和美国材料与试验协会（ASTM）制定的共识标准保持一致。
