UNI EN ISO 11137-3 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS
27-08-2022
01-01-2006
Foreword
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
5.3 Calibration of dosimetry system
6 Establishing the maximum acceptable dose
7 Establishing the sterilization dose
8 Installation qualification
9 Operational qualification
9.1 General
9.2 Gamma irradiators
9.3 Electron beam irradiators
9.4 X-ray irradiators
10 Performance qualification
10.1 General
10.2 Gamma and X-ray
10.3 Electron beam
11 Routine monitoring and control
11.1 General
11.2 Frequency of dose measurements
Annex A (informative) Mathematical modelling
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directives 90/385/EEC concerning active implantable
medical devices, 93/42/EEC concerning medical devices
and 98/79/EEC concerning in vitro diagnostic medical
devices
Bibliography
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