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EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

Publication date:   Aug 17, 2011

General information

99.60 Withdrawal effective   May 19, 2021

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
Legislation 98/79/EC
93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC
90/385/EEC

Active implantable medical devices

Harmonized/Supporting
Legislation 90/385/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 13824:2004

NOW

WITHDRAWN
EN ISO 13408-6:2011
99.60 Withdrawal effective
May 19, 2021

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 13408-6:2011/A1:2013

REVISED BY

PUBLISHED
EN ISO 13408-6:2021

Relations

Adopted from ISO 13408-6:2005 IDENTICAL