BS EN ISO 3826-3:2007
Current
The latest, up-to-date edition.
Plastics collapsible containers for human blood and blood components Blood bag systems with integrated features
Hardcopy , PDF
English
30-04-2008
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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
Describes requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).
| Committee |
CH/212
|
| DevelopmentNote |
Renumbers and supersedes BS ISO 3826-3. 2007 version incorporates corrigendum to BS ISO 3826-3. Together with BS EN ISO 1135-4 and BS EN ISO 3826-1, supersedes BS 2463-1(1990) and BS 2463-2(1989). Supersedes 07/30166744 DC. (04/2008)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO3826 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this document.
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 ISO3826-1, which specifies the requirements of conventional containers, this part of ISO3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO3826 does not cover automated blood collection systems.
Unless otherwise specified, all tests specified in this part of ISO3826 apply to the plastic container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO3826-1, where applicable.
| 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 |
| ISO 3826-3:2006 | Identical |
| SN EN ISO 3826-3:2008 | Identical |
| NF EN ISO 3826-3 : 2008 | Identical |
| I.S. EN ISO 3826-3:2007 | Identical |
| EN ISO 3826-3:2007 | Identical |
| NBN EN ISO 3826-3 : 2008 | Identical |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
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