Standard

NS-EN ISO 11137-2:2006

Aug 2006 Withdrawn

Note: This standard has a new edition: NS-EN ISO 11137-2:2015

Corrigendums and amendments are bought separately.

Language English

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Abstract

ISO 11137-2:2006 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

Document information

Standard from SN
Published: 1 August 2006
Withdrawn: 1 September 2007
Edition: 2006-04
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 93/42/EEC, 90/385/EEC

Product Relations

Replaces: NS-EN ISO 11137-2:2007
Replaced by: NS-EN ISO 11137-2:2007
Replaces: NS-EN 552:1994
Adopted from: EN ISO 11137-2:2006 , 0

NS-EN ISO 11137-2:2006

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NS-EN ISO 11137-2:2015

NS-EN ISO 11137-2:2013

NS-EN ISO 11137-2:2012

NS-EN ISO 11137-2:2007