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EN ISO 11137-3:2017

Current

Current

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

Published date

07-26-2017

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Summarise this standard

European foreword
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

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

Committee
CEN/TC 204
DevelopmentNote
Supersedes EN 552. (07/2006)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

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