Categories Of Medical Devices

Published Time: 2023-10-09 | Regulatory Compliance

Categories Of Medical Devices

Understanding the classification of medical devices is crucial for determining the appropriate sterilization method, such as Ethylene Oxide (EO) sterilization. Devices are categorized based on their risk level, duration of contact, and invasiveness.

CLASS I

Low Risk Devices

Includes products with Level I sterility or those with simple measurement functions. These are generally non-invasive or contact intact skin.

Examples: Examination gloves, syringes, gravity infusion sets, gauze pads, reusable surgical instruments, non-electronic thermometers, and tonometers.

CLASS IIa

Low to Medium Risk

Includes products introduced into the body through orifices or surgical means (short-term), substances altering physiological processes in non-dangerous ways, and non-invasive disinfectants.

Examples: Contact lenses, ultrasound devices, dental crowns, extracorporeal circulation loops, urinary probes, surgical drainage tubes, needles, and blood pressure monitors.

CLASS IIb

Medium to High Risk

Includes implantable products, devices that manage substances/energy in potentially hazardous ways, and products used to diagnose vital functions or prevent STDs.

Examples: Condoms, intraocular lenses, tissue-filled implants, non-absorbable surgical sutures, blood bags, hemodialyzers, external defibrillators, X-ray equipment, and anesthesia machines.

CLASS III

High Risk Devices

This category involves life-sustaining or implantable products, especially those in contact with the central nervous or circulatory systems, or containing pharmaceutical/animal derivatives.

Examples: Heart valves, hip/breast replacements, stents, cardiovascular catheters, absorbable sutures, and antimicrobial dressings.