EU publishes list of device standards:
This article was originally published in Clinica
The European Commission has published its latest list of medical device standards which manufacturers may follow to ensure compliance with the essential requirements of the Medical Devices Directive and the Active Implantable Medical Devices Directive. These cover risk analysis and biological evaluation of medical devices. The Official Journal of May 9 lists a further eight standards which give the presumption of compliance with the essential requirements of the Medical Devices Directive. These cover pressure regulators for use with medical gases; pulse oximeters; sphygmomanometers; sterilisers; catheters; laryngoscopes; anaesthetic gas monitors and spectacle lenses.
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