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BS EN ISO 13408-5:2011

Current

Current

The latest, up-to-date edition.

Aseptic processing of health care products Sterilization in place

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2011

€217.36
Excluding VAT

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

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.

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
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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