15/30282559 DC : 0
Superseded
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BS EN ISO 11137-3 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL
Hardcopy , PDF
English
08-31-2017
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
BS EN ISO 11137-3.
| Committee |
CH/198
|
| DocumentType |
Draft
|
| Pages |
46
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
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