Name: EN ISO 13408-4:2011
Brand: CEN

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

Published date

06-29-2011

Publisher

Comite Europeen de Normalisation

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.

Committee	CEN/TC 204
DevelopmentNote	Supersedes EN 13824. (07/2011)
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current
Supersedes	EN 13824 : 2004

Standards	Relationship
SN EN ISO 13408-4 : 2011	Identical
PN EN ISO 13408-4 : 2012	Identical
ISO 13408-4:2005	Identical
NEN EN ISO 13408-4 : 2011	Identical
NBN EN ISO 13408-4 : 2011	Identical
I.S. EN ISO 13408-4:2011	Identical
DIN EN ISO 13408-4:2011-09	Identical
BS EN ISO 13408-4:2011	Identical
UNI EN ISO 13408-4 : 2011	Identical
UNE-EN ISO 13408-4:2011	Identical
NS EN ISO 13408-4 : 2011	Identical
NF EN ISO 13408-4 : 2011	Identical

ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
DIN EN ISO 13408-1:2015-12	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
BS EN ISO 13408-1:2015	Aseptic processing of health care products General requirements
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BS EN 556-2:2015	Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
PREN 556-2 : DRAFT 2014	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
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UNE-EN 556-2:2016	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
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EN 556-2:2015	Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
I.S. EN ISO 13408-1:2015	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
14/30273161 DC : 0	BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES

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