Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
Abstract
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.
DIN EN ISO 3826-3:2008-03 (E)
Plastics collapsible containers for human blood and blood components – Part 3:
Blood bag systems with integrated features (ISO 3826 -3:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Dimensions and designation …………………………………………………………………………………………..6
5 Design ……………………………………………………………………………………………………………………………8
6 Requirements ……………………………………………………………………………………………………………….10
7 Packaging …………………………………………………………………………………………………………………….11
8 Labelling ……………………………………………………………………………………………………………………….12
9 Anticoagulant and/or preservative solution ……………………………………………………………………13
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Device ……………………………………………….14