scope:

NVN-ISO/TS 19930 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.In addition, this document provides a)background information on the assurance of sterility and sterility assurance level, and b)guidance on strategies that can allow the achievement of a maximal SAL of 10-6. This document describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6.