BS PD ISO/TS 19930:2017提供了关于确定作为基于风险的方法的一部分要考虑的方面的指南，该方法用于为最终灭菌、一次性使用的医疗保健产品选择无菌保证水平（SAL），该产品无法承受处理，以达到最大10-6的SAL。交叉引用:ISO 14040ICH Q1A（R2）EN 556-1ISO 22442-1ISO 20857ISO 9001ISO 14161ISO 9004ISO 11137-1ANSI/AAMI ST67ISO 10993ISO 22442-2ISO 11137-2ISO 14971ISO 14937ISO/IEC指南51AAMI TIR17ISO 22442-3ISO 11607-2ISO 11135-1ISO 13408ISO 14160ISO 90003ISO 17665-1ISO 14001ISO 11607-1ISO 9000:2005（R09）Ed 3ISO 25424: 2009年版1ISO/TS 13004:2013ASTM F1980-07购买本文件时可获得的所有现行修订均包含在购买本文件中。

BS PD ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6.Cross References:ISO 14040ICH Q1A(R2)EN 556-1ISO 22442-1ISO 20857ISO 9001ISO 14161ISO 9004ISO 11137-1ANSI/AAMI ST67ISO 10993ISO 22442-2ISO 11137-2ISO 14971ISO 14937ISO/IEC Guide 51AAMI TIR17ISO 22442-3ISO 11607-2ISO 11135-1ISO 13408ISO 14160ISO 90003ISO 17665-1ISO 14001ISO 11607-1ISO 9000:2005 (R09) Ed 3ISO 25424:2009 Ed 1ISO/TS 13004:2013ASTM F1980 - 07All current amendments available at time of purchase are included with the purchase of this document.