subject: Online Medical Supplies [print this page] The classification of medical devices is shown below. There are basically four classes, ranging from low risk to high risk.
* Class I (including Is & Im)
* Class IIa
* Class IIb
* Class III
The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. A Notified Body is a public or private organization that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilized or are not used to measure a function) can be put on the market purely by self-certification.
The European classification depends on rules that involve the medical device's duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.
Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packaging should also show harmonized pictograms and EN standardized logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don't reuse, etc.
Based on the above classes there are different kinds of online medical supply.
Aspirators
An aspirator, also called an educator-jet pump or filter pump, is a device that produces vacuum by means of the Venturi effect. In an aspirator, fluid (liquid or gaseous) flows through a tube which then narrows. When the tube narrows, the fluid's speed increases, and because of the Venturi effect, its pressure decreases. Vacuum is taken from this point.
External Pace Maker
A pacemaker (or artificial pacemaker, so as not to be confused with the heart's natural pacemaker) is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's native pacemaker is not fast enough, or there is a block in the heart's electrical conduction system. Modern pacemakers are externally programmable and allow the cardiologist to select the optimum pacing modes for individual patients. Some combine a pacemaker and defibrillator in a single implantable device. Others have multiple electrodes stimulating differing positions within the heart to improve synchronization of the lower chambers of the heart.
Pulse Oximeter
A pulse oximeter is a medical device that indirectly monitors the oxygen saturation of a patient's blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photoplethysmograph. It is often attached to a medical monitor so staff can see a patient's oxygenation at all times. Most monitors also display the heart rate. Portable, battery-operated pulse oximeters are also available for home blood-oxygen monitoring. The original oximeter was made by Milliken in the 1940s.[1] The precursor to today's modern pulse oximeter was developed in 1972, by Aoyagi at Nihon Kohden using the ratio of red to infrared light absorption of pulsating components at the measuring site. It was commercialized by Biox in 1981. The device did not see wide adoption in the United States until the late 1980s.
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by: Manish Sing
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