NEN EN ISO 11137-1 : 2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control
        of nonconforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
   5.4 Environmental considerations
6 Process and equipment characterization
   6.1 Process
   6.2 Equipment
7 Product definition
8 Process definition
   8.1 Establishing the maximum acceptable dose
   8.2 Establishing the sterilization dose
   8.3 Specifying the maximum acceptable dose and the
        sterilization dose
   8.4 Transference of maximum acceptable, verification
        or sterilization dose between radiation sources
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 Demonstration of continued effectiveness
   12.2 Recalibration
   12.3 Maintenance of equipment
   12.4 Requalification of equipment
   12.5 Assessment of change
Annex A (informative) Guidance
ANNEX ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directives 90/385/EEC concerning active implantable
         medical devices, 93/42/EEC concerning medical
         devices and 98/79/EEC concerning in vitro diagnostic
         medical devices
Bibliography

Defines requirements for the development, validation and routine control of a radiation sterilization process for medical devices.