Introduction - Specification for labelling consumables used in therapeutic product production - Chapter 27
This chapter defines the requirements of the UK Blood and Tissue Services (UKBTS) 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