27.1: Introduction

This chapter defines the requirements of the UK Blood Transfusion Services for the labelling by the manufacturer of ‘stand-alone’ consumable medical devices (critical consumables) used in the production of therapeutic blood components and tissues.

These devices are distinct from blood bags (either individual bags or within a blood pack or apheresis set assembly, including those pre-filled with anticoagulant or preservatives) that are described in Chapter 26 and tissue containers which are described in Chapter 24.

This specification applies to:

• stand-alone intravenous (IV) and other solutions including:
  • preservatives and additives (e.g. platelet additive solution)
  •  saline
  •  dextrose and dextran
  •  anticoagulants
  •  pathogen inactivators
     
•  filters (e.g. leucodepletion, prion filtration)
   
•  fluid transfer sets
   
• injection sites, clamps, one-way valves.