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Normas DIN – AENOR
DIN EN ISO 13408-2:2017-04

DIN EN ISO 13408-2:2017-04

Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO/DIS 13408-2:2017); German and English version prEN ISO 13408-2:2017 / Note: Date of issue 2017-03-10

Traitement aseptique des produits de santé - Partie 2: Filtration stérile (ISO/DIS 13408-2:2017); Version allemande et anglaise prEN ISO 13408-2:2017 / Attention: Date de parution 2017-03-10

Aseptische Herstellung von Produkten für die Gesundheitsfürsorge - Teil 2: Sterilfiltration (ISO/DIS 13408-2:2017); Deutsche und Englische Fassung prEN ISO 13408-2:2017 / Achtung: Erscheinungsdatum 2017-03-10

Fecha Anulación:
2018-06 /Withdrawn
Equivalencias internacionales:

ISO/DIS 13408-2 (2017-03)

prEN ISO 13408-2 (2017-03)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 13408-2:2018-06

Resumen:
This part of ISO 13408 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. This part of ISO 13408 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e. g. bacterial whole-cell vaccines). This part of ISO 13408 is not applicable to High Efficiency Particulate Air (HEPA) filters. This International Standard does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Keywords:
Aseptic, CE marking, Clean rooms, Containers, Definitions, Filter system, Filters, Filtration, Fluids, Guide books, Health services, Insulators, Maintenance, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Occupational medicine, Personnel, Processing, Public health protection, Quality assurance, Quality management, Specification (approval), Sterile, Sterility, Sterilization (hygiene), Surveillance (approval), Validation
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