Deliverable
Free preview
Price
Language
ILNAS-EN ISO 3826-4:2015
Edition
08/2015
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
- € 51.80 / copy
Abstract
ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826.
The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid.
ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.
Status
| Standard - Active |
Origin
| Technical Committee : |
| CEN/TC 205 : Non-active medical devices |
Implementation
| start of the vote on the project | 10/10/2013 | date of ratification (dor) | 23/04/2015 | |||
| end of the vote on the project | 10/03/2014 | date of anouncement (doa) | 30/11/2015 | |||
| start of the vote on the final project | 22/01/2015 | date of publication (dop) | 29/02/2016 | |||
| end of the vote on the final project | 22/03/2015 | date of withdrawal (dow) | 29/02/2016 |
|
Publication Official Journal
of the Grand-Duchy of Luxembourg |
31/12/2015 |
| Reference | Mémorial A N° 264 |
Relations
| Relations to international standards |
| ISO 3826-4 |
| ISO 3826-4:2015 |
International Classification for Standards (ICS codes) :
| 11.040.20 : Transfusion, infusion and injection equipment |
