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AS/NZS ISO 11137.3:2006 PDF
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Sterilization of health care products — Radiation, Part 3: Guidance on dosimetric aspects
Adopts ISO 11137-3:2006 to provide guidance on AS/NZS ISO 11137 parts 1 and 2 on dosimetry.
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Measurement of dose
5 Selection and calibration of dosimetry systems
5.1 General
5.2 Selection of dosimetry systems
5.2.1
5.2.2
5.3 Calibration of dosimetry system
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
6 Establishing the maximum acceptable dose
6.1
6.2
6.3
7 Establishing the sterilization dose
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
7.11
7.12
8 Installation qualification
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
9 Operational qualification
9.1 General
9.2 Gamma irradiators
9.2.1
9.2.2
9.2.3
9.2.4
9.2.5
9.2.6
9.2.7
9.2.8
9.2.9
9.2.10
9.2.11
9.3 Electron beam irradiators
9.3.1
9.3.2
9.3.3
9.3.4
9.3.5
9.3.6
9.3.7
9.3.8
9.3.9
9.4 X-ray irradiators
9.4.1
9.4.2
9.4.3
9.4.4
9.4.5
9.4.6
9.4.7
9.4.8
9.4.9
9.4.10
9.4.11
10 Performance qualification
10.1 General
10.1.1
10.1.2
10.1.3
10.1.4
10.2 Gamma and X-ray
10.2.1
10.2.2
10.2.3
10.2.4
10.2.5
10.2.6
10.2.7
10.2.8
10.2.9
10.2.10
10.2.11
10.3 Electron beam
10.3.1
10.3.2
10.3.3
10.3.4
10.3.5
10.3.6
10.3.7
10.3.8
10.3.9
10.3.10
11 Routine monitoring and control
11.1 General
11.2 Frequency of dose measurements
Annex A
A.1 General
A.2 Types of model
A.2.1 General
A.2.2 Point Kernel
A.2.3 Monte Carlo
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
Bibliography
Cited references in this standard
Content history
[Superseded]
[Superseded]
DR 06399
AS/NZS ISO 11137.3-2006 REC:2017
| Published | 19/12/2006 |
|---|---|
| Pages | 15 |
