SR EN ISO 13408-6:2011

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

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.

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General information

Status : Withdrawn
Approval date : 10/31/2011
Withdrawal date : 5/31/2021
Number of pages : 31
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN 13824:2005
Replaced by SR EN ISO 13408-6:2021
Amended by SR EN ISO 13408-6:2011/A1:2013