1 Scope
2 Normative references
3 Definitions
4 General
4.1 Personnel
4.2 Process development and product compatibility
4.3 Sterilization process
4.4 Equipment
4.5 Calibration
4.6 Maintenance
5 Validation
5.1 General
5.2 Commissioning
5.3 Performance qualification - physical
5.4 Performance qualification - microbiological
5.5 Certification of validation
5.6 Revalidation
6 Process control and monitoring
7 Product release
7.1 Conventional product release
7.2 Parametric release
Annexes
A General aspects of sterilization
B Validation
C Process control and monitoring [6]
D Product release [7]