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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
Published
ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product.
ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer.
ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.
Legislation related to this standard
WITHDRAWN
EN 13824:2004
PUBLISHED
EN ISO 13408-4:2011
60.60
Standard published
Jun 29, 2011