PD ISO/TS 19930:2017 PDF

1   Scope This document 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 .

NOTE It is not a requirement of the International Standards for development , validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ...