Standard

SN EN ISO 13408-5:2011

Sep 2011 Current

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Abstract

ISO 13408-5:2006 specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-5:2006 applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.

Products specifications

Standard from INB
Published: September 1 2011
Effective: September 1 2011
Document type: EN
Pages
ISBN:

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

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 90/385/EWG, 93/42/EWG

Product Relations

Adopted from: ISO 13408-5:2006, IDT
Replaces: SN EN 13824:2005

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Version history History (2)