EN ISO 3826-3:2007
Current
The latest, up-to-date edition.
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
12-12-2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
5 Design
6 Requirements
7 Packaging
8 Labelling
9 Anticoagulant and/or preservative solution
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC Medical Device
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.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 3826-3:2008-03 | Identical |
| NS EN ISO 3826-3 : 1ED 2007 | Identical |
| NEN EN ISO 3826-3 : 2008 | Identical |
| PN EN ISO 3826-3 : 2008 | Identical |
| I.S. EN ISO 3826-3:2007 | Identical |
| BS EN ISO 3826-3:2007 | Identical |
| NBN EN ISO 3826-3 : 2008 | Identical |
| ISO 3826-3:2006 | Identical |
| SS-EN ISO 3826-3:2007 | Identical |
| UNE-EN ISO 3826-3:2008 | Identical |
| EN 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) |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| I.S. EN 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) |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers |