Healthcare

This European Standard specifies general requirements for medical devices carried in air ambulances and used therein and outside hospitals and clinics in situations where the ambient conditions can differ from normal indoor conditions.

This European Standard does not cover the requirements for approval and registration of the vehicle and the training of the staff which is the responsibility of the authority/authorities in the country where the ambulance is to be registered.

This International Standard specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on manufacturers' instructions for use, marking and packaging.

This International Standard applies to operating lights, irrespective of the technology of the light source.

Excluded are auxiliary light sources, e.g. from dental handpieces and dental headlamps.

Also excluded are operating lights which are specifically designed for use in oral surgery.

This International Standard specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components.

This International Standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labelling information.

Specified qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard but it is recommended that to assess possible biological or toxicological hazards, reference should be made to ISO 7405 and ISO 10993-1.