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ISO 13408-5:2006

Aseptic processing of health care products — Part 5: Sterilization in place

Nov 15, 2006

General information

90.93     Nov 8, 2021

ISO

ISO/TC 198

International Standard

11.080.01  

English   French  

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Published

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO 13408-5:2006
90.93 Standard confirmed
Nov 8, 2021

National adoptions

SRPS ISO 13408-5:2010  
ISS

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

60.60   Standard published

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