ISO 11137-2:2013
2013-06
Abstract
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Buy together
ISO 11137 Radiation sterilization package
This package provides the foundational requirements (Part 1), specific methods for establishing the sterilization dose (Part 2), essential guidance on accurate dose measurement (Part 3), and practical advice on process control (TS Part 4), offering a holistic approach from development to routine monitoring.
- ISO 11137-1:2025
- ISO 11137-2:2013
- ISO 11137-3:2017
- ISO/TS 11137-4:2020
General information
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Status: PublishedPublication date: 2013-06Stage: International Standard to be revised [90.92]
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Edition: 3Number of pages: 68
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Technical Committee :ISO/TC 198ICS :11.080.01
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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 2022
Life cycle
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Previously
WithdrawnISO 11137-2:2012
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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 11137-2:2013/Amd 1:2022
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00
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Will be replaced by
Under developmentISO/AWI 11137-2
