This standard was last reviewed and confirmed in 2016.
Therefore this version remains current.
Abstract
PreviewISO 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.
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Status: PublishedPublication date: 2006-04
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Edition: 1Number of pages: 37
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- ICS :
- 11.080.01 Sterilization and disinfection in general
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en
| Format | Language | |
|---|---|---|
| std 1 166 | ||
| std 2 166 | Paper |
- CHF166
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Life cycle
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Previously
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Now
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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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Approval
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Publication
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90
Review
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95
Withdrawal
Corrigenda / Amendments
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/DIS 11137-1
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