AAMI ISO 13408-4 : 2005

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption
of ISO 13408-4:2005
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Process and equipment characterization
6 Cleaning agent characterization
7 CIP process
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) - Description of
        sampling methods
Annex B (informative) - Calculation examples
        for acceptance criteria
Bibliography

Describes the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.