ISO 11137-1:2006
Withdrawn
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Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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19-04-2006
09-04-2025
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
- specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
- detail specified requirements for designating a medical device as sterile;
- specify a quality management system for the control of all stages of production of medical devices;
- specify requirements for occupational safety associated with the design and operation of irradiation facilities;
- specify requirements for the sterilization of used or reprocessed devices.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11137-1. Together with ISO 11137-2 and ISO 11137-3, Supersedes ISO 11137. (05/2006)
|
| DocumentType |
Standard
|
| Pages |
37
|
| ProductNote |
NEW CHILD AMD 2 2018 IS NOW ADDED. NEW CHILD AMD 1 2013 IS NOW ADDED.
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes | |
| UnderRevision |
| Standards | Relationship |
| JIS T 0806-1:2015 | Identical |
| JIS T 0806-1:2022 | Identical |
| GOST ISO 11137-1 : 2011 | Identical |
| NF EN ISO 11137-1 : 2016 | Identical |
| NBN EN ISO 11137-1 : 2015 | Identical |
| NEN EN ISO 11137-1 : 2015 | Identical |
| NS EN ISO 11137-1 : 2015 | Identical |
| I.S. EN ISO 11137-1:2015 | Identical |
| PN EN ISO 11137-1 : 2015 | Identical |
| AS/NZS ISO 11137.1:2006 | Identical |
| SS-EN ISO 11137-1:2015 | Identical |
| I.S. EN ISO 11137-1:2015/A2:2019 | Identical |
| BS EN ISO 11137-1:2015 | Identical |
| EN ISO 11137-1:2015 | Identical |
| DIN EN ISO 11137-1:2015-11 | Identical |
| DIN EN ISO 11137-1:2006-07 | Identical |
| BS EN ISO 11137-1 : 2006 | Equivalent |
| I.S. EN ISO 11137-1:2006 | Equivalent |
| IS/ISO 11137 : Part 1 : 2006 | Identical |
| GOST R ISO 11137-1 : 2008 | Identical |
| AAMI ISO 11137-1:2006 | Identical |
| UNE-EN ISO 11137-1:2015 | Identical |
| JIS T 0806-1:2010 | Identical |
| AAMI ISO 11137-1 : 2006 : R2010 | Identical |
| UNE-EN ISO 11137-1:2006 | Identical |
| UNE-EN ISO 11137-1:2007 | Identical |
| AAMI ISO 11137-1 : 2006 : INC : AMD 1 : 2013 : R201000 | Identical |
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