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 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Design
5.1 Leucocyte filter
5.2 Pilot samples
5.3 Access line needle and return line needle
5.4 Needle stick protection device
5.5 Pre-collection sampling device
5.6 Red blood cell storage bag
5.7 Plasma storage bag
5.8 Platelet storage bag
5.9 Post-collection sampling device
5.10 Collection and transfer tube(s)
5.11 Outlet port(s)
5.12 Suspension
6 Requirements
6.1 General
6.2 Physical requirements
6.2.1 Conditions of manufacture
6.2.2 Sterilization
6.2.3 Transparency
6.2.4 Coloration
6.2.5 Thermal stability
6.2.6 Water vapour transmission for plastics containers prefilled with storage solution or anticoagulant
6.2.7 Resistance to leakage
6.2.8 Insertion force
6.2.9 Pull force
6.2.10 Leakage after closure piercing
6.2.11 Particulate contamination
6.3 Chemical requirements
6.3.1 Requirements for the raw container or sheeting
6.3.2 Requirements for the test fluid
6.4 Biological requirements
6.4.1 General
6.4.2 Impermeability for microorganisms
6.4.3 Compatibility
7 Packaging
7.1 General
7.2 Shelf-life
7.3 Over-package materials
7.4 Over-package sealing
7.5 Over-package strength
7.6 Arrangement of components in the over-package
8 Labelling
8.1 General
8.2 Label on plastics containers
8.3 Label on over-package
8.4 Package insert or instructions for use
8.5 Label on shipping box
8.6 Label requirements
9 Anticoagulant and/or preservative solution
Annex A (normative) Chemical tests
Annex B (normative) Physical tests
Annex C (normative) Biological tests
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Design
5.1 Leucocyte filter
5.2 Pilot samples
5.3 Access line needle and return line needle
5.4 Needle stick protection device
5.5 Pre-collection sampling device
5.6 Red blood cell storage bag
5.7 Plasma storage bag
5.8 Platelet storage bag
5.9 Post-collection sampling device
5.10 Collection and transfer tube(s)
5.11 Outlet port(s)
5.12 Suspension
6 Requirements
6.1 General
6.2 Physical requirements
6.2.1 Conditions of manufacture
6.2.2 Sterilization
6.2.3 Transparency
6.2.4 Coloration
6.2.5 Thermal stability
6.2.6 Water vapour transmission for plastics containers prefilled with storage solution or anticoagulant
6.2.7 Resistance to leakage
6.2.8 Insertion force
6.2.9 Pull force
6.2.10 Leakage after closure piercing
6.2.11 Particulate contamination
6.3 Chemical requirements
6.3.1 Requirements for the raw container or sheeting
6.3.2 Requirements for the test fluid
6.4 Biological requirements
6.4.1 General
6.4.2 Impermeability for microorganisms
6.4.3 Compatibility
7 Packaging
7.1 General
7.2 Shelf-life
7.3 Over-package materials
7.4 Over-package sealing
7.5 Over-package strength
7.6 Arrangement of components in the over-package
8 Labelling
8.1 General
8.2 Label on plastics containers
8.3 Label on over-package
8.4 Package insert or instructions for use
8.5 Label on shipping box
8.6 Label requirements
9 Anticoagulant and/or preservative solution
Annex A (normative) Chemical tests
Annex B (normative) Physical tests
Annex C (normative) Biological tests
Bibliography