ANSI/AAMI/ISO 13408-7:2012(R2018)
Current
The latest, up-to-date edition.
Hardcopy , PDF
English
08-17-2018
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 13408-7:2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
11 Test for sterility
Annex A (informative) - Risk assessment for aseptic
processing - Quality risk management method
Annex B (informative) - Selection of a sample for
testing for microbial contamination
Annex C (informative) - Testing options for process
simulation
Bibliography
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