Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Determination of an appropriate SAL for a health care
product to be labeled 'STERILE'
Annexes
Annex A (informative) - Background and historical application
of sterility assurance
Annex B (informative) - Examples of terminally sterilized
products and sterility assurance levels that have
historically been selected
Annex C (informative) - Guidance on Performing a Risk Analysis
for Selecting an SAL for a product that cannot be
sterilized to a 10[-6] SAL
Annex D (informative) - Bibliography