Aseptic processing of health care products Sterilization in place

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-31-2011

Publisher

British Standards Institution

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.

Committee	CH/198
DevelopmentNote	Together with BS EN ISO 13408-1, 2, 3, 4 and 6, it supersedes BS EN 13824. (10/2011)
DocumentType	Standard
Pages	28
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN 13824:2004

Standards	Relationship
ISO 13408-5:2006	Identical
EN ISO 13408-5:2011	Identical

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
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