ISO 11137-1:2006
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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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
Hardcopy , PDF
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Withdrawn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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