UNI EN ISO 11137-3 : 2006

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Measurement of dose
5 Selection and calibration of dosimetry systems
   5.1 General
   5.2 Selection of dosimetry systems
   5.3 Calibration of dosimetry system
6 Establishing the maximum acceptable dose
7 Establishing the sterilization dose
8 Installation qualification
9 Operational qualification
   9.1 General
   9.2 Gamma irradiators
   9.3 Electron beam irradiators
   9.4 X-ray irradiators
10 Performance qualification
   10.1 General
   10.2 Gamma and X-ray
   10.3 Electron beam
11 Routine monitoring and control
   11.1 General
   11.2 Frequency of dose measurements
Annex A (informative) Mathematical modelling
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

Gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry.