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BS EN ISO 11137-3:2017

BS EN ISO 11137-3:2017

$189.07

Sterilization of health care products. Radiation – Guidance on dosimetric aspects of development, validation and routine control

Published By Publication Date Number of Pages
BSI 2017 50
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This document 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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms, definitions and symbols
3.1 General
11 3.2 Symbols
12 4 Measurement of dose
4.1 General
4.1.1 Direct and indirect dose measurements
4.1.2 Dosimetry systems
4.1.3 Best estimate of dose
13 4.2 Dosimetry system selection and calibration
4.2.1 General
4.2.2 Selection of dosimetry systems
4.2.3 Calibration of dosimetry systems
14 4.3 Dose measurement uncertainty
4.3.1 General concepts
4.3.2 The Guide to the expression of uncertainty in measurement (GUM) methodology
15 4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty
16 5 Establishing the maximum acceptable dose
17 6 Establishing the sterilization dose
18 7 Installation qualification
19 8 Operational qualification
8.1 General
8.2 Gamma irradiators
21 8.3 Electron beam irradiators
23 8.4 X-ray irradiators
25 9 Performance qualification
9.1 General
26 9.2 Gamma irradiators
9.2.1 Loading pattern
27 9.2.2 Dosimetry
28 9.2.3 Analysis of dose mapping data
9.3 Electron beam irradiators
9.3.1 Loading pattern
30 9.3.2 Dosimetry
9.3.3 Analysis of dose mapping data
31 9.4 X-ray irradiators
9.4.1 Loading pattern
32 9.4.2 Dosimetry
33 9.4.3 Analysis of dose mapping data
10 Routine monitoring and control
10.1 General
34 10.2 Frequency of dose measurements
35 Annex A (informative) Mathematical modelling
38 Annex B (informative) Tables of references for dosimetry-related testing during IQ/OQ/PQ
41 Annex C (informative) Tolerances associated with doses used in sterilization dose setting/substantiation in ISO 11137‑2 and ISO/TS 13004
42 Annex D (informative) Application of dose measurement uncertainty in setting process target doses
48 Bibliography

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BS EN ISO 11137-3:2017
$189.07