ANSI/AAMI/ISO 13408-4:2005(R2014)
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
13-10-2014
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
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