01/560508 DC : DRAFT FEB 2001

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