Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English, French, Russian

Published date

09-22-2006

Publisher

International Organization for Standardization

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	ISO/TC 76
DevelopmentNote	Supersedes ISO/DIS 3826-3 (09/2006)
DocumentType	Standard
Pages	9
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
NF EN ISO 3826-3 : 2008	Identical
NBN EN ISO 3826-3 : 2008	Identical
NEN ISO 3826-3 : 2006	Identical
NEN EN ISO 3826-3 : 2008	Identical
NS EN ISO 3826-3 : 1ED 2007	Identical
I.S. EN ISO 3826-3:2007	Identical
PN EN ISO 3826-3 : 2008	Identical
SAC GB 14232-3 : 2011	Identical
SN EN ISO 3826-3:2008	Identical
UNI EN ISO 3826-3 : 2008	Identical
SS-EN ISO 3826-3:2007	Identical
UNE-EN ISO 3826-3:2008	Identical
BS ISO 3826-3 : 2006	Identical
BS EN ISO 3826-3:2007	Identical
EN ISO 3826-3:2007	Identical
DIN EN ISO 3826-3:2008-03	Identical

DIN EN ISO 3826-4:2015-12	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
DIN EN ISO 3826-4 E : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
13/30273308 DC : 0	BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
I.S. EN ISO 3826-1:2013	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
15/30290736 DC : 0	BS EN ISO 10993-4 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD
DIN EN ISO 3826-1:2013-09	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
UNI EN ISO 3826-1 : 2013	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS
EN ISO 10993-4:2017	Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
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 10993-4:2017	Biological evaluation of medical devices Selection of tests for interactions with blood
ISO 3826-1:2013	Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
BS EN ISO 3826-1:2013	Plastics collapsible containers for human blood and blood components Conventional containers
UNE-EN ISO 3826-1:2013	Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
EN ISO 3826-1:2013	Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)
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)
UNE-EN ISO 10993-4:2018	Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
I.S. EN ISO 10993-4:2017	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
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

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ISO 3826-3:2006

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