Standard

SN EN ISO 11137-2:2012

Jun 2012 Withdrawn

Note: Latest version: SN EN ISO 11137-2:2015

Existing or new amendments and versions must be purchased separately.

Language English French German

Services Online + Pdf CHF 159.00 Online CHF 136.00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

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.

Products specifications

Standard from INB
Published: June 1 2012
Withdrawn: September 1 2013
Effective: June 1 2012
Document type: EN
Pages
ISBN:

ICS: 11.080.01
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 171

Product Relations

Replaced by: SN EN ISO 11137-2:2013
Adopted from: ISO 11137-2:2012, IDT
Replaces: SN EN ISO 11137-2:2007

SN EN ISO 11137-2:2012

Create subscription

SN EN ISO 11137-2:2015

SN EN ISO 11137-2:2013