BAS EN ISO 15747:2013
Plastični spremnici za intravenozne injekcije
Opšte informacije
Status: Povučen
Broj strana: 18
Jezik: Engleski
Izdanje: 2.
Metoda usvajanja: Proglašavanje
Datum objave: 12.06.2013
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
Životni ciklus
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Izvorni dokument i stepen usklađenosti
- EN ISO 15747:2011, identičan
- ISO 15747:2010, identičan