CLASSIFICATION OF MEDICAL DEVICES

Biocompatibility is a measure of how compatible a medical device is with a biological system. The purpose of performing biocompatibility testing is to determine the suitability of a device for human use and to see if the use of the device has potentially harmful physiological effects.

As the International Organization for Standardization (ISO) states: "The purpose of ISO 10993 is to protect people from the potential risks arising from the use of medical devices."

Classification of Medical Devices

Medical devices are classified according to the form and duration of contact with the body. Classification of medical devices facilitates the identification of appropriate data sets. During the evaluation of any device that does not fall into one of the classifications described, the general principles of ISO 10993 should be followed. Some devices may be included in more than one classification, in such a case, an evaluation should be made according to each classification.

Classification According to Body

Devices in contact with the surface; These devices include medical devices that come into contact with the following places.

a) Devices that only come in contact with the intact skin surface

EXAMPLES: Electrodes, external prostheses, fixation bands, compression bandages, and various types of monitors.

b) Devices that come into contact with intact mucosal membranes

EXAMPLES: Contact lenses, urinary catheters, intravaginal and intestinal devices (stomach tubes, sigmoidoscopes, colonoscopes, gastroscopes), intra-tracheal tubes, bronchoscopes, some dental prostheses and orthodontic devices.

c) Devices that come into contact with injured or also damaged body surfaces

EXAMPLES: Dressings or therapeutic devices and occlusive patches for ulcers, burns and granulation tissue.

External Transmission Devices

External communication devices should be classified according to the contact of these devices with the application places listed below.

a) Devices that come into contact with the bloodstream at one point and serve as a route for entry into the vascular system

EXAMPLES: Solution delivery sets, extension sets, transfer sets and blood donation sets.

b) Devices in contact with tissue, bone or pulp / dentine systems.

EXAMPLES: Laparoscopes, arthroscopes, drainage systems, dental cements, dental filling materials, and skin staples.

c) Devices that come into contact with circulating blood

EXAMPLES: Intravenous catheters, temporary pacemaker (pacemaker) electrodes, oxygen generators, extracorporeal oxygen generator tubes and accessories, dialysis devices, dialysis tubes and accessories, hemoadsorbents and immunadsorbents.

Implant (implantable) Devices

These devices should be classified according to the contact with the application places listed below.

a) Tissue / bone - Devices that come into contact with bone, especially.

EXAMPLES: Orthopedic nails, plates, replaceable joints, bone prostheses, bone plaster and intraosseous devices.

Especially devices that come into contact with tissue and tissue fluid.

EXAMPLES: Pacemakers, drug delivery devices, neuromuscular sensors and simulators, replaceable ligaments, breast implants, artificial pharynx (larynx), subperiosteal implants, vascular clamps and intrauterine devices.

b) Blood - Devices that come into contact with blood especially.

EXAMPLES: Pacemaker electrodes, artificial arterovenous fistulas, heart valves, transplant vascular tissues (grafts), internal drug delivery catheters, and ventricular assist devices.

Classification According to Contact Time

It should be classified as follows according to the contact time foreseen in the medical devices.

a) Limited exposure (A) - Devices with a cumulative single, multiple or repeated use or contact time of up to 24 hours.

b) Long term exposure (B) - Devices with a cumulative duration of single, multiple or repeated prolonged use or contact possibly exceeding 24 hours but not exceeding 30 days.

c) Permanent contact (C) - Devices with a cumulative single, multiple or repeated long-term use or contact time exceeding 30 days.

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