BS EN ISO 11137-3:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Radiation Guidance on dosimetric aspects of development, validation and routine control
Hardcopy , PDF
English
23-08-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Measurement of dose
5 Establishing the maximum acceptable dose
6 Establishing the sterilization dose
7 Installation qualification
8 Operational qualification
9 Performance qualification
10 Routine monitoring and control
Annex A (informative) - Mathematical modelling
Annex B (informative) - Tables of references for
dosimetry-related testing during IQ/OQ/PQ
Annex C (informative) - Tolerances associated with
doses used in sterilization dose setting/substantiation
in ISO 11137-2 and ISO/TS 13004
Annex D (informative) - Application of dose measurement
uncertainty in setting process target doses
Bibliography
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