Med Device Technol. 2006 Nov-Dec;17(9):34-5.
Some of the important points of the revised ISO 11607, Packaging for Terminally Sterilised Medical Devices, are reviewed here. In addition, the contents of a Technical Information Report (TIR), which is scheduled to be approved and published in early 2007, are described. This TIR will provide in-depth guidance on how to comply with the requirements of the standard.
本文回顾了修订后的ISO 11607《最终灭菌医疗器械包装》的一些要点。此外,还介绍了一份计划于2007年初批准并发布的技术信息报告(TIR)的内容。这份TIR将为如何符合该标准的要求提供深入指导。