Abstract
Ïã¸ÛÁùºÏ²Ê¿ª½± 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. Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
Ïã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
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 :Ïã¸ÛÁùºÏ²Ê¿ª½±/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
WithdrawnÏã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2012
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Now
PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)-
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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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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.PublishedÏã¸ÛÁùºÏ²Ê¿ª½± 11137-2:2013/Amd 1:2022
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00
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Will be replaced by
Under developmentÏã¸ÛÁùºÏ²Ê¿ª½±/AWI 11137-2
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)