Medical Devices Directive 93/42/EEC

Medical Devices Directive 93/42/EEC classifies devices according to the potential hazards related to their use , the expected duration of contact with a patient and the expected invasivness of the application.

If a product is deemed to conform to the Medical Devices Directive it must carry a CE mark on its packaging, and may also provide a statement of its classification. ../../

In addition, the properties of medical devices are described by a range of standards to which the devices should conform. ../../

Classification of Devices ../../

Class I ../../
Noninvasive devices, for example examination gloves :entry into a bodily orifice is not considered invasive.

Isolation mask,isolation gown etc

Class I Sterile ../../
Sterilised class I devices, for example sterile procedure gloves.

Class I Measuring ../../
Class I devices that perform a measurement, for example a thermometer.

Class II a ../../
products are short term invasive devices, for example surgical gloves.

Class II b ../../
Products that are included are contraceptive devices or devices intended to have a biological effect.

Class III ../../
 Products that are included are pace makers and devices which come in to direct contact with the central nervous system.