scope:

General

This standard describes safety and performance requirements for disposable micro-filters used for the removal of microaggregates from blood or blood products during transfusion.

Inclusions

Included within the scope of this standard are disposable micro-filters for blood and blood-derivative transfusions for adult populations only. These are sometimes also referred to as microaggregate filters. 

Exclusions

Excluded from the scope of this standard are filters used for extracorporeal service and other blood filters not intended for blood transfusion. Also excluded are components of standard infusion sets designed to remove readily visible blood clots only.

Note: For an explanation of the need for this standard, as well as the rationale for its provisions, see Appendix A.