BS EN ISO 11137-3:2017 – TC:2020 Edition
$246.62
Tracked Changes. Sterilization of health care products. Radiation – Guidance on dosimetric aspects of development, validation and routine control
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 104 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 54 | National foreword |
| 56 | European foreword |
| 59 | Foreword |
| 60 | Introduction |
| 61 | 1 Scope 2 Normative references 3 Terms, definitions and symbols 3.1 General |
| 63 | 3.2 Symbols |
| 64 | 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 |
| 65 | 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 |
| 66 | 4.3 Dose measurement uncertainty 4.3.1 General concepts 4.3.2 The Guide to the expression of uncertainty in measurement (GUM) methodology |
| 67 | 4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty |
| 68 | 5 Establishing the maximum acceptable dose |
| 69 | 6 Establishing the sterilization dose |
| 70 | 7 Installation qualification |
| 71 | 8 Operational qualification 8.1 General 8.2 Gamma irradiators |
| 73 | 8.3 Electron beam irradiators |
| 75 | 8.4 X-ray irradiators |
| 77 | 9 Performance qualification 9.1 General |
| 78 | 9.2 Gamma irradiators 9.2.1 Loading pattern |
| 79 | 9.2.2 Dosimetry |
| 80 | 9.2.3 Analysis of dose mapping data 9.3 Electron beam irradiators 9.3.1 Loading pattern |
| 82 | 9.3.2 Dosimetry 9.3.3 Analysis of dose mapping data |
| 83 | 9.4 X-ray irradiators 9.4.1 Loading pattern |
| 84 | 9.4.2 Dosimetry |
| 85 | 9.4.3 Analysis of dose mapping data 10 Routine monitoring and control 10.1 General |
| 86 | 10.2 Frequency of dose measurements |
| 87 | Annex A (informative) Mathematical modelling |
| 90 | Annex B (informative) Tables of references for dosimetry-related testing during IQ/OQ/PQ |
| 93 | Annex C (informative) Tolerances associated with doses used in sterilization dose setting/substantiation in ISO 11137‑2 and ISO/TS 13004 |
| 94 | Annex D (informative) Application of dose measurement uncertainty in setting process target doses |
| 100 | Bibliography |
