BS EN ISO 11137-3:2017
Current
The latest, up-to-date edition.
Sterilization of health care products. Radiation Guidance on dosimetric aspects of development, validation and routine control
Hardcopy , PDF
English
23-08-2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and symbols
4 Measurement of dose
5 Establishing the maximum acceptable dose
6 Establishing the sterilization dose
7 Installation qualification
8 Operational qualification
9 Performance qualification
10 Routine monitoring and control
Annex A (informative) - Mathematical modelling
Annex B (informative) - Tables of references for
dosimetry-related testing during IQ/OQ/PQ
Annex C (informative) - Tolerances associated with
doses used in sterilization dose setting/substantiation
in ISO 11137-2 and ISO/TS 13004
Annex D (informative) - Application of dose measurement
uncertainty in setting process target doses
Bibliography
Provides 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.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 04/30081279 DC. (03/2007) Together with BS EN ISO 11137-1 and BS EN ISO 11137-2, it supersedes BS EN 552. (06/2007) Supersedes 15/30282559 DC. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
This document gives guidance on meeting the requirements in ISO11137‑1 and ISO11137‑2 and in ISO/TS13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.