AAMI 11137 3 2017
$75.64
ANSI/AAMI/ISO 11137-3-2017 – Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 49 |
Guidance on dosimetry for radiation sterilization of health care products.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11137-3:2017; Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 10 | Background on the adoption of ISO 11137-3:2017 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms, definitions and symbols 3.1 General |
| 15 | 3.2 Symbols |
| 16 | 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 |
| 17 | 4.2 Dosimetry system selection and calibration 4.2.1 General 4.2.2 Selection of dosimetry systems 4.2.3 Calibration of dosimetry system |
| 18 | 4.3 Dose measurement uncertainty 4.3.1 General concepts 4.3.2 The GUM methodology |
| 19 | 4.3.3 Radiation sterilization specific aspects of dose measurement uncertainty |
| 20 | 5 Establishing the maximum acceptable dose |
| 21 | 6 Establishing the sterilization dose |
| 22 | 7 Installation qualification |
| 23 | 8 Operational qualification 8.1 General 8.2 Gamma irradiators |
| 25 | 8.3 Electron beam irradiators |
| 26 | 8.4 X-ray irradiators |
| 28 | 9 Performance qualification 9.1 General |
| 29 | 9.2 Gamma 9.2.1 Loading pattern |
| 30 | 9.2.2 Dosimetry 9.2.2.1 Dosimeter placement |
| 31 | 9.2.2.2 Replicate dose mapping exercises 9.2.3 Analysis of dose mapping data 9.3 Electron beam 9.3.1 Loading pattern |
| 32 | 9.3.2 Dosimetry 9.3.2.1 Dosimeter placement |
| 33 | 9.3.2.2 Replicate dose mapping exercises 9.3.3 Analysis of dose mapping data 9.4 X-ray 9.4.1 Loading pattern |
| 34 | 9.4.2 Dosimetry 9.4.2.1 Dosimeter placement |
| 35 | 9.4.2.2 Replicate dose mapping exercises 9.4.3 Analysis of dose mapping data |
| 36 | 10 Routine monitoring and control 10.1 General 10.2 Frequency of dose measurements |
| 37 | Annex A (informative) Mathematical modelling A.1 General A.2 Types of model A.2.1 General A.2.2 Point Kernel A.2.3 Monte Carlo |
| 38 | A.3 Use of models A.3.1 Design of irradiators A.3.2 Operation of gamma and X-ray irradiators A.3.3 Operation of electron beam irradiators |
| 39 | Annex B (informative) Tables of references for dosimetry-related testing during IQ/OQ/PQ B.1 Installation qualification Table B.1—Electron beam and X-ray (not applicable for gamma) |
| 40 | B.2 Operational qualification Table B.2—Gamma, electron beam and X-ray |
| 41 | B.3 Performance qualification Table B.3—Gamma, electron beam and X-ray |
| 42 | Annex C (informative) Tolerances associated with doses used in sterilization dose setting/substantiation in ISO 11137-2 Table C.1—Tolerances associated with doses used in sterilization dose setting/substantiation in ISO 11137-2 |
| 43 | Annex D (informative) Application of dose measurement uncertainty in setting process target doses D.1 General D.2 Standard uncertainty for setting process target doses (σprocess) |
| 44 | D.3 Selection of k values D.4 Radiation sterilization target dose values |
| 45 | Figure D.1—Process specifications |
| 46 | Figure D.2—Routine dose monitoring at minimum dose location |
| 47 | Figure D.3—Routine dose monitoring at a location remote from position of minimum and maximum dose but travelling with the product D.5 Calculating process target dose values that take uncertainty into account |
| 48 | Bibliography |
Related products
-
AAMI 11137 3 2017 R2023
ANSI/AAMI/ISO 11137-3:2017 (R2023) Sterilization Of Health Care Products – Radiation – Part 3: Guidance On…
-
AAMI TIR29 2012 RA 2017
AAMI TIR29:2012/(R)2017 – Guide for process characterization and control in radiation sterilization of medical devices…
-
AAMI 11137 2 2013 RA 2019:2017 Edition
ANSI/AAMI/ ISO 11137-2: 2013/(R)2019 – Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose…
