Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Assurance of sterility and sterility assurance
   level (SAL)
5 Management responsibility
6 Compatibility of product with a sterilization process
7 Strategies to achieve a maximal SAL of 10-6
8 Considerations if a maximal SAL of 10-6 cannot
   be achieved
9 Label claims
10 Establishing the sterilization process
11 Specific considerations for validation, routine
    monitoring and control, and product release
    from sterilization
12 Assessment of change
Annex A (informative) - Illustration of the sequence
        of activities in selecting and justifying an
        alternative SAL
Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 198