EN ISO 11137-3:2017
Current
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
07-26-2017
European foreword
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
ISO 11137-3:2017 gives 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 |
CEN/TC 204
|
| DevelopmentNote |
Supersedes EN 552. (07/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 11137-3:2017 | Identical |
| NF EN ISO 11137-3 : 2017 | Identical |
| NBN EN ISO 11137-3 : 2006 | Identical |
| NEN EN ISO 11137-3 : 2017 | Identical |
| NS EN ISO 11137-3 : 2017 | Identical |
| I.S. EN ISO 11137-3:2017 | Identical |
| PN EN ISO 11137-3 : 2017 | Identical |
| SS-EN ISO 11137-3:2017 | Identical |
| DIN EN ISO 11137-3:2017-11 | Identical |
| BS EN ISO 11137-3:2017 | Identical |
| DIN EN ISO 11137-3:2015-08 (Draft) | Identical |
| UNE-EN ISO 11137-3:2018 | Identical |
| UNE-EN ISO 11137-3:2007 | Identical |