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: