15/30282559 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
08-31-2017
English
Foreword
Introduction
1 Scope
2 Normative References
3 Terms and definitions
4 Measurement of Dose
5 Measurement of dose to product
6 Establishing the maximum acceptable dose
7 Establishing the sterilization dose
8 Installation qualification
9 Operational qualification
10 Performance qualification
11 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
Annex D (informative) - Establishment and application
of total uncertainty, sigma[total]
Bibliography
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