NBN EN ISO 11607-2 : 2006 AMD 1 2014

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 packaging
Annex A (informative) - Process development
Annex ZA (informative) - Relationship between this International
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC on medical
                         devices
Bibliography

Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.