scope:

General

This standard describes safety and performance requirements for disposable filters used for the reduction of leukocytes from blood or blood components before, during, or after storage.

Inclusions

Included within the scope of this standard are disposable filters for the reduction of leukocyte content of blood and blood components. These are sometimes also referred to as leukocyte reduction filters.

Exclusions

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

NOTE-For an explanation of the need for this standard, and the rationale for its provisions, see annex A.