Podaci o nacrtu
Oznaka:prEN ISO 3826-3
Odbor:HZN/TU S1
Ime odbora:Zdravlje, okoliš i medicinska oprema 1
Nacrt objavljen za komentiranje:2026-03-17
Rok za komentiranje:2026-04-04
Broj komentara:0
Contact email:nacrti(at)hzn.hr
Područje primjene nacrta:
ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).
The integrated features refer to:
leucocyte filter;
pre-donation sampling device;
top and bottom bag;
platelet storage bag;
needle stick protection device.
In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units.
Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.