Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
6 Selection of supplier
7 Biological indicators in process development
8 Biological indicators in sterilization validation
9 Biological indicators in routine monitoring
10 Results
11 Application of biological indicator standards
12 Culture conditions
13 Third-party requirements
14 Personnel training
15 Storage and handling
16 Disposal of biological indicators
Annex A (informative) - Microbiological inactivation kinetics
                        and enumeration techniques
Annex B (informative) - Process challenge devices
Annex C (informative) - Formulae for fraction negative methods
                        for D value calculations
Annex D (informative) - Examples of documentation for biological
                        indicators prepared by the user
Annex E (informative) - Calculation of z value
Annex F (informative) - D value determination by survivor curve
                        method
Annex G (informative) - Survival-kill response characteristics
Bibliography

Abstract

This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 198
Supersedes	ISO/DIS 14161 : 60.00 (2009)