This standard was last reviewed and confirmed in 2018.
Therefore this version remains current.
Abstract
PreviewISO 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.
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Status: PublishedPublication date: 2013-06
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Edition: 3Number of pages: 68
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- ICS :
- 11.080.01 Sterilization and disinfection in general
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| Format | Language | |
|---|---|---|
| std 1 178 | PDF + ePub | |
| std 2 178 | Paper |
- CHF178
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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
Corrigenda / Amendments
PublishedISO 11137-2:2013/Amd 1:2022
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00
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