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Eurofins Medical Device Testing’s Notified Body services are authorised to award CE Mark certification for EU Medical Device Directives 93/42/EEC &, 2007/47/EC, for active Medical Electrical Equipment, non-active Medical Devices and in vitro diagnostic medical devices.

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5.5 ISO Certification: In addition to the above tests, all medical face masks must be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user's skin.