Regulation and product standards for medical applications

In Europe the import and manufacture of medical devices is regulated by the European Union's Medical Devices Regulation 2017/745. This Regulation is in place to ensure that medical devices sold in Europe will not be harmful or pose any health risk.

European Pharmacopoeia

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:

3.1.1.1. 'Materials based on plasticised polyvinyl chloride for containers for human blood and blood components and for containers for aqueous solutions for intravenous infusion'

3.1.1.2. '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 Pharmacopoeia

A 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

tris(2-ethylhexyl) trimellitate

Often known as TOTM

bis(2-ethylhexyl) terephthalate

Often known as DOTP or DEHT

Medical devices must comply to strict international quality standards

In addition to these monographs there are a wide range of international quality standards to which products must comply. Biological testing criteria are covered in EN/ISO10993 'Biological Evaluation of Medical Devices'. Additionally, many devices manufactured in the EU also have to conform to other international criteria such as the United States Pharmacopoeia.