France acts against non-conforming sterilisation firm:
This article was originally published in Clinica
The French health ministry has issued a decree banning medical devices that have been sterilised by irradiation by Coating Industries based in the Rhone area of France. According to a Decision published in the Journal officiel of November 25, the putting on the market, distribution and export of all such products sterilised by irradiation has been suspended until the company can guarantee that its activities are in accordance with the European standard EN 552 for the validation and control of medical devices sterilised by irradiation, or its international equivalent, ISO 11137. The company is neither allowed to sterilise by irradiation products on behalf of other companies nor to put such products on the market under its own name during this period.
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