Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
3.1 Aseptic processing
3.2 Bioburden
3.3 Media Fills
3.4 Medical device
3.5 Sterility
3.6 Sterile
3.7 Terminally-sterilized
3.8 Test for sterility
4 Requirements
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography