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ISO 11137-2:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

09-03-2018

Language(s)

French, English

Published date

03-15-2012

ISO 11137-2:2011 specifies methods of 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 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.

DocumentType
Standard
Pages
76
PublisherName
International Organization for Standardization
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
UNE-EN ISO 11137-2:2012 Identical

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US$73.00
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