I.S. EN ISO 11137-1:2015

National Foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (informative) - Guidance
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 90/385/EEC
         on active implantable medical devices
Annex ZB (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this
         European Standard and the Essential Requirements of
         EU Directive 98/79/EC on in vitro diagnostic
         medical devices

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