04/30101215 DC : DRAFT APR 2004

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
  4.1 Quality systems
  4.2 Sampling
  4.3 Test methods
  4.4 Documentation
5 Validation of packaging processes
  5.1 General
  5.2 Installation qualification (IQ)
  5.3 Operational qualification (OQ)
  5.4 Performance qualification (PQ)
  5.5 Formal approval of the process validation
  5.6 Process control and monitoring
  5.7 Process changes and revalidation
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid path
Annex A (informative) Process development
Bibliography
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on medical devices