{"id":3133,"date":"2020-09-28T11:42:00","date_gmt":"2020-09-28T09:42:00","guid":{"rendered":"https:\/\/dev.francescaricci.it\/medical-devices-and-risk-classes-an-overview\/"},"modified":"2022-07-12T10:52:20","modified_gmt":"2022-07-12T08:52:20","slug":"medical-devices-and-risk-classes-an-overview","status":"publish","type":"post","link":"https:\/\/www.medics3d.com\/en\/medical-devices-and-risk-classes-an-overview\/","title":{"rendered":"Medical Devices and Risk Classes: An Overview"},"content":{"rendered":"\t\t
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The classification criterion is fundamentally based on the complexity of the device and on the potential risk that it represents for the patient in the event of a malfunction: Class I devices, which can be produced for the external help of the patient, are low-critical and low-risk devices (wheelchairs, stethoscopes, etc.); those of classes IIa and IIb are medium and medium\/high risk devices (many electromedical devices belong to these two categories); high-risk devices (for example, vascular catheters) are classified in Class III.<\/p>

The complexity and potential risk of Medicsl Devices (and therefore their belonging to a certain class of risk) are determined by three elements: the level of invasiveness, the possible dependence on an energy source and the duration of the contact time with the patient\u2019s body.<\/p>

A Medical Device is non-invasive if it does not penetrate into any part of the body, either through the skin or through the orifices (for example, eyeglasses or crutches). On the contrary, all devices that penetrate even partially are considered invasive (regardless of how they are inserted into the patient\u2019s body).<\/p>

The category of invasive Medical Devices is in turn divided into three subgroups:\u00a0<\/span><\/p>