Regulation and product standards for medical applications
As well as EU Regulation 2017/745, there are various European Pharmacopoeia Monographs for polymeric materials, in force from January 1,1999. They provide strict regulation concerning the absence of any physiological hazard in pharmaceutical packaging made from rigid PVC. These monographs give guidance on both the chemical compositional requirements of components for medical devices as well as chemical toxicity testing for potential extraction of either inorganic or organic contaminants. Medical devices which involve blood storage generally have the most demanding criteria.
The specific monographs for flexible PVC are:
184.108.40.206. 'Materials based on plasticised polyvinyl chloride for containers for human blood and blood components and for containers for aqueous solutions for intravenous infusion'
220.127.116.11. 'Materials based on plasticised polyvinyl chloride for tubing used in sets for the transfusion of blood and blood components'
3.2.4. 'Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components'
3.2.5. 'Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution'
Four new PVC plasticisers added to PharmacopoeiaA November 2017 revision included four new PVC plasticisers, in addition to DEHP:
cyclohexane 1,2-dicarboxylic acid, diisononyl ester
Often known as Hexamoll DINCH
butyryl tri-n-hexyl citrate
Often known as BTHC
Often known as TOTM
Often known as DOTP or DEHT