ISO 3826-1:2013
Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.
ISO 3826-1:2013 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in ISO 3826-1:2013 apply to the plastics container as prepared ready for use.
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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Table tab_a
Figure fig_1
Table tab_1
Section sec_5.6
Section sec_5.6.1
Section sec_5.6.2
Section sec_5.6.3
Section sec_5.6.4
Section sec_5.6.5
Section sec_5.7
Section sec_5.8
Section sec_5.8.1
Section sec_5.8.2
Section sec_5.8.3
Section sec_5.8.4
Section sec_5.9
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2
Section sec_6.2.2.3
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.2.5
Section sec_6.2.6
Section sec_6.2.7
Section sec_6.2.8
Section sec_6.3
Section sec_6.3.1
Table tab_2
Section sec_6.3.2
Table tab_3
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_6.4.3
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.4
Section sec_7.5
Section sec_7.6
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_9
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_A.4.1
Annex sec_A.4.2
Annex sec_A.4.3
Annex sec_A.4.4
Annex sec_A.4.4.1
Annex sec_A.4.4.2
Annex sec_A.4.5
Annex sec_A.4.6
Annex sec_A.4.7
Annex sec_A.4.7.1
Annex sec_A.4.7.2
Annex sec_A.4.7.2.1
Annex sec_A.4.7.2.2
Annex sec_A.4.7.2.3
Annex sec_A.4.7.2.4
Annex sec_A.4.7.2.5
Table tab_A.1
Annex sec_A.4.7.3
Annex sec_A.4.7.3.1
Annex sec_A.4.7.3.2
Annex sec_A.4.7.3.3
Annex sec_A.4.7.3.4
Annex sec_A.4.8
Annex sec_A.4.8.1
Annex sec_A.4.8.2
Annex sec_A.4.8.3
Annex sec_A.4.8.4
Annex sec_A.4.9
Annex sec_A.4.10
Annex sec_A.4.10.1
Annex sec_A.4.10.1.1
Annex sec_A.4.10.1.2
Annex sec_A.4.10.1.3
Annex sec_A.4.10.2
Annex sec_A.4.10.2.1
Annex sec_A.4.10.2.2
Annex sec_A.4.10.2.3
Annex sec_A.4.10.3
Annex sec_A.4.10.4
Annex sec_A.4.10.5
Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.3
Annex sec_B.4
Annex sec_B.4.1
Annex sec_B.4.2
Annex sec_B.4.3
Annex sec_B.5
Table tab_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.2.1
Annex sec_C.2.2
Annex sec_C.3
Annex sec_C.4
Annex sec_C.5
Annex sec_C.6
Annex sec_C.6.1
Annex sec_C.6.2
Annex sec_C.6.3
Annex sec_C.7
Table tab_C.1
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
4.1 Dimensions
4.2 Designation example
5 Design
5.1 General
5.2 Air content
5.3 Emptying under pressure
5.4 Pilot samples
5.5 Rate of collection
5.6 Collection and transfer tube(s)
5.7 Blood-taking needle
5.8 Outlet port(s)
5.9 Suspension
6 Requirements
6.1 General
6.2 Physical requirements
6.3 Chemical requirements
6.4 Biological requirements
7 Packaging
8 Labelling
8.1 General
8.2 Label on plastics container
8.3 Label on over-package
8.4 Label on shipping box
8.5 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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Section sec_1
Section sec_2
Section sec_3
Section sec_3.1
Section sec_3.2
Section sec_4
Section sec_4.1
Section sec_4.2
Section sec_5
Section sec_5.1
Section sec_5.2
Section sec_5.2.1
Section sec_5.2.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Table tab_a
Figure fig_1
Table tab_1
Section sec_5.6
Section sec_5.6.1
Section sec_5.6.2
Section sec_5.6.3
Section sec_5.6.4
Section sec_5.6.5
Section sec_5.7
Section sec_5.8
Section sec_5.8.1
Section sec_5.8.2
Section sec_5.8.3
Section sec_5.8.4
Section sec_5.9
Section sec_6
Section sec_6.1
Section sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.2.1
Section sec_6.2.2.2
Section sec_6.2.2.3
Section sec_6.2.3
Section sec_6.2.4
Section sec_6.2.5
Section sec_6.2.6
Section sec_6.2.7
Section sec_6.2.8
Section sec_6.3
Section sec_6.3.1
Table tab_2
Section sec_6.3.2
Table tab_3
Section sec_6.4
Section sec_6.4.1
Section sec_6.4.2
Section sec_6.4.3
Section sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.3
Section sec_7.4
Section sec_7.5
Section sec_7.6
Section sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.3
Section sec_8.4
Section sec_8.5
Section sec_9
Annex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex sec_A.4.1
Annex sec_A.4.2
Annex sec_A.4.3
Annex sec_A.4.4
Annex sec_A.4.4.1
Annex sec_A.4.4.2
Annex sec_A.4.5
Annex sec_A.4.6
Annex sec_A.4.7
Annex sec_A.4.7.1
Annex sec_A.4.7.2
Annex sec_A.4.7.2.1
Annex sec_A.4.7.2.2
Annex sec_A.4.7.2.3
Annex sec_A.4.7.2.4
Annex sec_A.4.7.2.5
Table tab_A.1
Annex sec_A.4.7.3
Annex sec_A.4.7.3.1
Annex sec_A.4.7.3.2
Annex sec_A.4.7.3.3
Annex sec_A.4.7.3.4
Annex sec_A.4.8
Annex sec_A.4.8.1
Annex sec_A.4.8.2
Annex sec_A.4.8.3
Annex sec_A.4.8.4
Annex sec_A.4.9
Annex sec_A.4.10
Annex sec_A.4.10.1
Annex sec_A.4.10.1.1
Annex sec_A.4.10.1.2
Annex sec_A.4.10.1.3
Annex sec_A.4.10.2
Annex sec_A.4.10.2.1
Annex sec_A.4.10.2.2
Annex sec_A.4.10.2.3
Annex sec_A.4.10.3
Annex sec_A.4.10.4
Annex sec_A.4.10.5
Annex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.3
Annex sec_B.4
Annex sec_B.4.1
Annex sec_B.4.2
Annex sec_B.4.3
Annex sec_B.5
Table tab_B.1
Annex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.2.1
Annex sec_C.2.2
Annex sec_C.3
Annex sec_C.4
Annex sec_C.5
Annex sec_C.6
Annex sec_C.6.1
Annex sec_C.6.2
Annex sec_C.6.3
Annex sec_C.7
Table tab_C.1
Reference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions and designation
4.1 Dimensions
4.2 Designation example
5 Design
5.1 General
5.2 Air content
5.3 Emptying under pressure
5.4 Pilot samples
5.5 Rate of collection
5.6 Collection and transfer tube(s)
5.7 Blood-taking needle
5.8 Outlet port(s)
5.9 Suspension
6 Requirements
6.1 General
6.2 Physical requirements
6.3 Chemical requirements
6.4 Biological requirements
7 Packaging
8 Labelling
8.1 General
8.2 Label on plastics container
8.3 Label on over-package
8.4 Label on shipping box
8.5 Label requirements
9 Anticoagulant and/or preservative solution
Annex A (normative) Chemical tests
Annex B (normative) Physical tests
Annex C (normative) Biological tests
Bibliography