NEN EN ISO 3826-1 : 2013

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 need
  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

Provides 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.