BAS EN ISO 15747:2020

Plastični spremnici za intravenske injekcije


Opće informacije
Status: Važeći
Broj strana: 22
Jezik: Engleski
Izdanje: 3.
Metoda usvajanja: Proglašavanje
Nadnevak objave: 30.09.2020
Tehnički komitet:
Direktiva:
93/42/EEC, Medicinska sredstva
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Apstrakt
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document 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. NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

Životni ciklus
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Izvorni dokument i stepen usklađenosti
  • EN ISO 15747:2019, identičan
  • ISO 15747:2018, identičan

Veza sa BAS standardima