{"id":8213,"date":"2023-05-24T00:55:24","date_gmt":"2023-05-23T22:55:24","guid":{"rendered":"https:\/\/www.amil-care.com\/2023\/05\/24\/dispositivi-medici-non-invasivi\/"},"modified":"2023-07-13T10:15:49","modified_gmt":"2023-07-13T08:15:49","slug":"non-invasive-medical-devices","status":"publish","type":"post","link":"https:\/\/www.amil-care.com\/en\/2023\/05\/24\/non-invasive-medical-devices\/","title":{"rendered":"What is a non-invasive medical device DN?"},"content":{"rendered":"

AMIL Care products for the medical sector are intended for the <\/span>sanitization of surfaces<\/span><\/b> such as equipment, operating tables, medical units, and of a precise category of devices: <\/span>non-invasive medical devices<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

We believe it is important to give an exhaustive explanation, and we will do so in this article, designed for all professionals, referring in particular to professional figures such as the Purchasing Manager in hospital facilities, the Medical Equipment Management Managers, Clinical Engineers (Aiic), Heads of safety and hygiene (HSE), and also Heads of clinical risk management.<\/span>\u00a0<\/span><\/p>\n

What is a medical device?<\/h2>\n

A <\/span>medical device <\/span><\/b>is any instrument, appliance, implant, substance, or other product used alone or in combination, for diagnostic and\/or therapeutic purposes. Its main action is not achieved by pharmacological means.<\/span>\u00a0<\/span><\/p>\n

All <\/span>medical devices <\/span><\/b>are classified according to their complexity and potential risk for the patient.<\/span>\u00a0<\/span><\/p>\n

The manufacturer of a device must indicate its intended use, from which will derive more specific characteristics, such as invasiveness, dependence, or nonreliance on an energy source, and contact time with the body.\u00a0<\/span>\u00a0<\/span><\/p>\n

Based on these characteristics, the classification will be assigned according to the rules set out <\/span>in Attachment IX, Legislative Decree no. 46 of 24 February 1997<\/span>.<\/span>\u00a0<\/span><\/p>\n

The <\/span>classification of medical devices <\/span><\/b>distinguishes class I, class IIa, class IIb, and class III.<\/span>\u00a0<\/span><\/p>\n

Class I<\/span><\/b> corresponds to the so-called “low-risk” devices, such as bandages, wheelchairs, scalpels, and corrective glasses. Furthermore, two sub-categories are Is, for devices supplied in a sterile state, and Im, for devices with a measuring function.<\/span>\u00a0<\/span><\/p>\n

Class Ila<\/span><\/b> corresponds to devices with “medium-low risk”, such as suture needles, forceps, and disinfectants for non-invasive <\/span>medical devices<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

Class Ilb<\/span><\/b> corresponds to devices with “medium-high risk”, such as incubators for newborns, dialysis instruments, and surgical lasers.<\/span>\u00a0<\/span><\/p>\n

Finally, <\/span>class IlI<\/span><\/b> corresponds to devices with “high risk”, such as absorbable sutures and bone and tissue substitutes of animal origin.<\/span>\u00a0<\/span><\/p>\n

Among the above classes, it is also possible to see a broader distinction <\/span>between invasive and non-invasive medical devices<\/span><\/b>.<\/span>\u00a0<\/span><\/p>\n

The first are those intended to penetrate the orifices of the body and are surgical or implantable devices inside the body. The latter, on the other hand, do not penetrate any part of the body.<\/span>\u00a0<\/span><\/p>\n

On the basis of the duration of use, the following are distinguished:<\/span>\u00a0<\/span><\/p>\n