This article is published by our Biomedical Trainer, Ms. Vennila Pandian.
The classification of biomedical equipment will be discussed in this article. It is often divided into two groups based on the applications it serves. That is Diagnostic and Therapeutic Equipment respectively. Diagnostic equipment, such as a stethoscope, thermometer, sphygmomanometer, and X-ray, is used for diagnosis. Therapeutic equipment is utilized for therapy such as a defibrillator, a ventilator, an oxygen concentrator, a massager, and so forth.
Biomedical equipment is divided into three categories based on risk considerations. There are three classes: Class 1, Class 2, and Class 3.
Class 1
Devices in class 1 are non-invasive and low-risk. Bandages, Walking Sticks, and Wheel Chairs are just a few examples.
There are two subcategories of Class 1 devices. Class 1s and Class 1m are the two types of classes.
Devices in the Class 1s category are also non-invasive. This category includes sterile gadgets. Exam gloves, colostomy bags, and oxygen masks are just a few examples.
Low-risk measurement devices are classified as Class 1m devices. For example, a thermometer, Non-invasive Blood pressure monitor, and Fingertip Pulse oximeter.
Class 2
There are two categories of devices in Class 2. That is, classes 2a and 2b.
Class 2a devices are low to medium risk and refer to devices that are placed in the body for a short period of time. The time range is from 1 hour to 30 days. For example Blood Transfusion tubes and catheters.
Devices in class 2b are slightly more complicated than those in class 2a. It is commonly medium to high risk, and devices are frequently placed in the body for periods of 30 days or longer. Examples include a Ventilator and a Patient Monitoring System.
Class 3
Class 3 devices are high-risk devices which is very important to sustaining life. For example Balloon catheters, Prosthetic heart valves, and Pacemaker.
Thank You
With Best Regards
Ms. Vennila Pandian
Biomedical Trainer, Head-Operation
fovea-Z Biomedical
ATHEENAPANDIAN PRIVATE LIMITED
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