Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Pre-selection of filters and filter assemblies
based on filter manufacturer's data
6 Fluid-specific selection criteria based
on filter user's data
7 Filtration process
7.1 Process parameters
7.2 Validation of fluid-specific microbial retention
by filters
7.2.1 Bacterial challenge test
7.2.2 Challenge fluid and challenge microorganisms
8 Filtration system design
9 Routine process
10 Process documentation
11 Maintenance and change control
12 Operator training
Annex A Basic information and quality certificates for
filter cartridges