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ISO 13408-6:2005

Aseptic processing of health care products — Part 6: Isolator systems
20. 6. 2005.
95.99   Povučen   13. 4. 2021.

Опште информације

95.99     13. 4. 2021.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

POVUČEN
ISO 13408-6:2005
95.99 Povučen
13. 4. 2021.

ISPRAVKE / IZMENE

POVUČEN
ISO 13408-6:2005/Amd 1:2013

REVIDIRAN OD

OBJAVLJEN
ISO 13408-6:2021

Nacionalna preuzimanja

SRPS ISO 13408-6:2010  
ISS

Aseptični postupci za zaštitu zdravlja - Deo 6: Izolatorski sistemi

95.99   Povučen

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