60.60 Standard published Jun 29, 2011
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
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.
Legislation related to this standard
WITHDRAWN
EN 13824:2004
PUBLISHED
EN ISO 13408-5:2011
60.60
Standard published
Jun 29, 2011