I.S. EN ISO 11137-3:2017
Current
The latest, up-to-date edition.
STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
Hardcopy , PDF
English
01-01-2017
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
National Foreword
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
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 |
ISO/TC 198
|
| DevelopmentNote |
Supersedes I.S. EN 552. (07/2006)
|
| DocumentType |
Standard
|
| Pages |
58
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11137-3 : 2017 | Identical |
| NEN EN ISO 11137-3 : 2017 | Identical |
| DIN EN ISO 11137-3:2015-08 (Draft) | Identical |
| NS EN ISO 11137-3 : 2017 | Identical |
| EN ISO 11137-3:2017 | Identical |
| NBN EN ISO 11137-3 : 2006 | Identical |
| ISO 11137-3:2017 | Identical |
| BS EN ISO 11137-3:2017 | Identical |
| DIN EN ISO 11137-3:2017-11 | Equivalent |
| UNE-EN ISO 11137-3:2007 | Identical |
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