Standards Development

Scope

This document 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 document. This part of ISO 3826 does not cover the specific portion of the aphaeresis set that pumps or centrifuges whole blood as an integrated feature

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;

— connections for storage solutions, anticoagulant, and replacement fluid;

— donor or patient access line(s);

— waste or removal bag;

— processing bag and collection bag.

This document specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by aphaeresis. This document can be used on automated or semi-automated blood collection systems. This document does not specify additional requirements for integrated features that are intended for removal from the aphaeresis set post procedure/donation for storage and transfusion.

NOTE 1 Annex D provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.

NOTE 2 Annex E provides recommendations regarding sustainability.

NOTE 3 Annex F provides information on attributive and variable testing.