Medical Products and Packaging

The United States Pharmacopeia (USP), which is responsible for establishing legally recognized product standards from drugs and other health-related articles, has considerable Influence worldwide. In the 1960s, methodology and requirements were established for plastics used for pharmaceutical containers and closures and these were subsequently adopted by manufacturers of medical devices. USP tests measure the biological reactivity of plastics in contact with mammaiian cell cultures (in vitro) and via implantation and injection of extractables into laboratory animals (in vivo). 

In Europe, medical devices are strictly regulated by the EU s Medical Device Directive (9 3/42/EEC). Other influential bodies are the World Health Organization (WHO), the European Commission, Canada Health, and the International Agency for Research on Cancer (lARC). 

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