BS ISO 13408-7 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
Hardcopy , PDF
31-08-2015
English
01-01-2012
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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