EN
SR EN ISO 13408-6:2011
Tratament aseptic pentru produse de îngrijire a sănătăţii. Partea 6: Sisteme izolatoare
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 :
Anulat
Data aprobării : 31.10.2011
Data anulării : 31.05.2021
Număr de pagini : 31
ICS : 11.080.01 Sterilizare si dezinfectare în general
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN 13824:2005
- Inlocuit prin SR EN ISO 13408-6:2021
- Modificat de SR EN ISO 13408-6:2011/A1:2013