BS EN ISO 3826-4:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Dimensions
5 Design
6 Requirements
7 Packaging
8 Labelling
9 Anticoagulant and/or preservative solution
Annex A (normative) - Chemical tests
Annex B (normative) - Physical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on Medical devices

Defines requirements, including performance requirements, for apheresis blood bag systems with integrated features.

This part of ISO3826 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 ISO3826.

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.

This part of ISO3826 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. This part of ISO3826 can be used on automated or semi-automated blood collection systems.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO3826.