BAS EN ISO 13408-1:2012
Aseptička izrada proizvoda za zdravstvenu njegu – dio 1: opći zahtjevi
Opšte informacije
Status: Povučen
Broj strana: 6
Jezik: Engleski
Izdanje: 1.
Metoda usvajanja: Proglašavanje
Datum objave: 08.06.2012
Tehnički komitet:
Direktiva:
90/385/EEC, Aktivna ugradiva medicinska sredstva
93/42/EEC, Medicinska sredstva;
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
93/42/EEC, Medicinska sredstva;
98/79/EC, Medicinska sredstva u in vitro dijagnostici;
...
Apstrakt
ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
Životni ciklus
...
Izvorni dokument i stepen usklađenosti
- EN ISO 13408-1:2011, identičan
- ISO 13408-1:2008, identičan