Revised standard offersmore device SAL options

摘要

A revised standard, published by the Association for the Advancement of Medical Instrumentation (AAMI), makes it easier for manufacturers to use a less-restrictive sterility assurance level (SAL) for medical devices that are sensitive to 10~6 sterilisation processes, enabling them to avoid a costlier alternative. "The previous version of ST67 was very restrictive in using SALs other than 10~6," said Trabue Bryans, co-chair of the AAMI Sterility Assurance Level Working Group, which developed the standard. A SAL of 10"6 is the probability that a single microorganism will survive for every million products sterilised. Some products cannot withstand such terminal sterilisation methods to reach the 10~6 level because of the materials used in the device or because of device design, said Gerry O'Dell, president of Gerry O 'Dell Consulting in Wesley Chapel, Florida, and a member of the working group.