ANSI/AAMI/ISO 11137-3:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
Hardcopy , PDF
04-08-2024
English
10-06-2017
Glossary of equivalent standards
Committee representation
Background on the adoption of ISO 11137-3:2017
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
Annex D (informative) - Application of dose
measurement uncertainty in setting process
target doses
Bibliography
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