Abstract
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.
General information
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Status: PublishedPublication date: 2006-04Stage: International Standard to be revised [90.92]
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Edition: 1Number of pages: 37
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Technical Committee :ISO/TC 198ICS :11.080.01
- RSS updates
Amendments
Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.
Amendment 1
Edition 2013
ISO 11137-1:2006/Amd 1:2013
60165
CHF
18
Convert Swiss francs (CHF) to your currency
Life cycle
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Previously
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Now
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00
Preliminary
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10
Proposal
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20
Preparatory
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30
Committee
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40
Enquiry
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50
Approval
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60
Publication
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90
Review
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95
Withdrawal
Amendments
Provide additional content; available for purchase; not included in the text of the existing standard.PublishedISO 11137-1:2006/Amd 1:2013
PublishedISO 11137-1:2006/Amd 2:2018
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00
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Will be replaced by
Under developmentISO/FDIS 11137-1