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ILNAS-EN ISO 13408-6:2011 Edition 06/2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
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Abstract

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Status

Standard - Withdrawn

Origin

Technical Committee :
CEN/TC 204 : Sterilization of medical devices

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices
98/79/EC : In vitro diagnostic medical devices

Implementation

start of the vote on the project      date of ratification (dor)    10/06/2011
end of the vote on the project      date of anouncement (doa)    30/09/2011
start of the vote on the final project    09/12/2010   date of publication (dop)    31/12/2011
end of the vote on the final project    09/05/2011   date of withdrawal (dow)    31/12/2011


Publication Official Journal
of the Grand-Duchy of Luxembourg
05/01/2012
Reference

Relations

Evolutions
ILNAS-EN ISO 13408-6:2021
ILNAS-EN ISO 13408-6:2011/A1:2013

Relations to older standards
ILNAS-EN 13824:2004

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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