EN ISO 13408-2:2018

European foreword
Endorsement notice
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Sterilizing filter characterization
6 Process and equipment characterization
7 Fluid definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilizing filtration
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the application
        of this document
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 90/385/EEC
         on active implantable medical devices
         [OJ L 189] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices [OJ L 169] aimed to be covered
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 98/79/EC on in vitro diagnostic
         medical devices [OJ L 331] aimed to be covered