BAS EN ISO 13408-1:2025
Aseptička obrada proizvoda za zdravstvenu zaštitu - Dio 1: Opći zahtjevi
Opće informacije
Status: Važeći
Broj strana: 82
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 18.06.2025
Tehnički komitet:
Direktiva:
2017/745, Uredba (EU) o medicinskim sredstvima
2017/746, Uredba (EU) o medicinskim sredstvim u in vitro dijagnostici;
2017/746, Uredba (EU) o medicinskim sredstvim u in vitro dijagnostici;
...
Apstrakt
This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products.
This document includes requirements and guidance relative to the overall topic of aseptic processing.
Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 13408-1:2024, identičan
- ISO 13408-1:2023, identičan